STEERABLE GUIDE CATHETER SGC0301Recalls & reported problems

Summary

The FDA's MAUDE database contains 389 adverse event reports that list this exact device (DI 08717648216824), received between Nov 28, 2016 and Sep 9, 2026 — classified as 5 deaths, 216 injuries, 168 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (129 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 389 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2026Positioning Failure; Physical Resistance/Sticking

  It was reported that a MitraClip procedure was performed to treat functional mitral regurgitation (MR) with a grade of 4 on a patient with an enlarged atrium. A steerable guide catheter (SGC) was prepared and inserted. However, to achieve a better trajectory, additional ¿+¿ knob was applied, and after applying ¼ ¿+¿, resistance was encountered. Troubleshooting was performed, but the knob would still not work. Therefore, the SGC was removed and replaced. A new SGC was inserted and the procedure was continued. A MitraClip XTR was inserted and deployed on the valve. However, during deployment, the clip suddenly opened from roughly to degrees to roughly 70 degrees. The clip was reported to be stable on the leaflets. The procedure was then discontinued, and the MR increased to a grade of 4+. There was no clinically significant delay in the procedure. The patient was then transferred to surgery for mitral valve replacement. The patient was reported to be recovering.The steerable guide catheter (SGC) device returned and analysis performed on (b)(6)2026 revealed a cable break.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50693835 ↗
• InjuryAug 5, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that on (b)(6) 2026, a patient presented with grade 4+ functional mitral regurgitation (MR) and a restricted posterior leaflet for a MitraClip procedure. During the procedure, the steerable guide catheter (SGC) was advanced on the guidewire. While advancing the SGC through the peripheral venous access, the guidewire became kinked. The SGC then perforated the iliac vein and the procedure was discontinued. The patient was transferred and successfully underwent the implantation of a covered stent in the iliac vein. The patient was stabilized. There were no MitraClips implanted, the MR remained at grade 4+. There were no clinically significant delays reported.

  Patient problems: Perforation of Vessels

  MAUDE report 50147394 ↗
• InjuryAug 3, 2026Air/Gas in Device

  It was reported that on 12 July 2026, a patient presented with grade 4+ functional mitral regurgitation (MR) and an enlarged atrium for a MitraClip procedure. During the procedure, when the steerable guide catheter (SGC) was advanced within the interatrial septum into the left atrium, air bubbles were visualized within the left atrium on echocardiography. The patient presented with ST-segment elevation and an air embolism was believed to have occurred but was unable to be visualized. The SGC was removed from the patient and the patient stabilized. A replacement SGC was selected and advanced successfully and three MitraClips were implanted successfully. The procedure was discontinued, the final MR was reduced to grade 1+. There were no adverse patient effects or clinically significant delays reported.

  Patient problems: Air Embolism; Low Blood Pressure/ Hypotension

  MAUDE report 50122045 ↗
• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that on (b)(6)2026, a patient presented with grade 4 functional mitral regurgitation (MR), restricted posterior leaflet for a Mitraclip procedure. During the procedure, physician inserted steerable guide catheter (SGC) into the left atrium. After confirming that there was no problem, guide wire and dilator was removed. Physician pumped the blood that had been extracted under negative pressure back into the left atrium. During the rinsing process of clip delivery system (CDS), physician noticed that the patient's heart had stopped beating. After a brief external cardiac compression, the patient's heart resumed beating. SGC was removed and procedure was discontinued. Patient was moved to intensive care unit. The final MR was grade 4. There were no adverse patient effects or clinically significant delays reported.

  Patient problems: Cardiac Arrest

  MAUDE report 50020378 ↗
• InjuryJun 24, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2026, A PATIENT PRESENTED WITH GRADE 4+ FUNCTIONAL MITRAL REGURGITATION (MR) AND AN ENLARGED ATRIUM FOR A MITRACLIP PROCEDURE. DURING THE PROCEDURE, THE STEERABLE GUIDE CATHETER (SGC) WAS ADVANCED WITHIN THE PATIENT. WHILE ADVANCING THE SGC IT BECAME LODGED IN THE POSTERIOR WALL OF THE LEFT ATRIUM. THE PATIENT'S HEART RATE AND BLOOD PRESSURE DROPPED AND VENTRICULAR FIBRILLATION WAS VISUALIZED. THE SGC WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS DISCONTINUED. THE FINAL MR REMAINED AT GRADE 4+. THERE WERE NO CLINICALLY SIGNIFICANT DELAYS REPORTED.

  Patient problems: Bradycardia; Low Blood Pressure/ Hypotension; Ventricular Fibrillation

  MAUDE report 25612635 ↗
• InjuryMay 1, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (b)(6) 2026, A PATIENT PRESENTED WITH GRADE 4 MITRAL REGURGITATION (MR) FOR A MITRACLIP PROCEDURE. DURING THE PROCEDURE, THE STEERABLE GUIDE CATHETER (SGC) WAS ADVANCED WITHIN THE PATIENT. WHEN THE SGC WAS ADVANCED WITHIN THE LEFT ATRIUM, A CARDIAC TAMPONADE WAS IDENTIFIED. THE SGC WAS REMOVED FROM THE PATIENT AND THE PATIENT WAS TRANSFERRED TO THE SURGICAL DEPARTMENT FOR TREATMENT. THE FINAL MR REMAINED UNCHANGED, NO CLIPS WERE IMPLANTED. THERE WERE NO CLINICALLY SIGNIFICANT DELAYS REPORTED.

  Patient problems: Cardiac Tamponade

  MAUDE report 25059095 ↗
• InjuryApr 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2026, A PATIENT PRESENTED WITH GRADE 4+ FUNCTIONAL MITRAL REGURGITATION (MR) FOR A MITRACLIP PROCEDURE. DURING THE PROCEDURE, THE STEERABLE GUIDE CATHETER (SGC) WAS ADVANCED WITHIN THE LEFT ATRIUM A THROMBUS WAS VISUALIZED. THE PHYSICIAN WAS CONCERNED THAT IT MAY HAVE BEEN CAUSED BY THE HYDROPHILIC COATING OF THE SGC AND THE PROCEDURE WAS DISCONTINUED. THE FINAL MR REMAINED AT GRADE 4+. THERE WERE NO CLINICALLY SIGNIFICANT DELAYS REPORTED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 25009966 ↗
• InjuryApr 21, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2026, A PATIENT PRESENTED WITH GRADE 4+ DEGENERATIVE MITRAL REGURGITATION (MR) FOR A MITRACLIP PROCEDURE. DURING THE PROCEDURE, THE STEERABLE GUIDE CATHETER (SGC) WAS ADVANCED WITHIN THE PATIENT AND PASSED THROUGH THE ATRIAL SEPTUM WHEN THE GUIDEWIRE TIP WAS INADVERTENTLY STEERED INTO THE LEFT ATRIUM APPENDAGE AND PUNCTURED IT. A PERICARDIAL EFFUSION DEVELOPED, THE PATIENT'S VITALS REMAINED STABLE. THE PROCEDURE WAS DISCONTINUED, THE SGC WAS REMOVED FROM THE PATIENT. THE FINAL MR REMAINED AT GRADE 4+. THERE WERE NO CLINICALLY SIGNIFICANT DELAYS REPORTED.

  Patient problems: Pericardial Effusion

  MAUDE report 24947910 ↗
• MalfunctionFeb 6, 2026Positioning Failure

  IT WAS REPORTED THAT DURING PREPARATION OF A STEERABLE GUIDE CATHETER (SGC). WHILE FLUSHING THE SGC, THE SGC COULD NOT BE DEFLECTED. THEREFORE, THE SGC WAS NOT USED AND WAS REPLACED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. DEVICE RETURNED AND ANALYSIS OF THE DEVICE DONE ON 13-JAN-2026 REVEALED A DETACHED SCREW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24281843 ↗
• MalfunctionJan 29, 2026Leak/Splash

  IT WAS REPORTED THAT ON (B)(6) 2026, A PATIENT PRESENTED WITH GRADE 4 DEGENERATIVE MITRAL REGURGITATION (MR) FOR A MITRACLIP PROCEDURE. DURING DEVICE PREPARATION, WHILE FLUSHING THE STEERABLE GUIDE CATHETER (SGC) THERE WAS A LEAK ON THE ONE-WAY VALVE AT THE TAIL END OF THE SGC WHICH ALLOWED FOR UNCONTROLLED AIR INTAKE. TROUBLESHOOTING WAS PREFORMED UNSUCCESSFULLY AND A REPLACEMENT SGC WAS SELECTED. THE PROCEDURE WAS PERFORMED SUCCESSFULLY, AND THE MR WAS EDUCED TO GRADE <1. THERE WERE NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAYS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24211161 ↗
• MalfunctionJan 23, 2026Leak/Splash

  IT WAS REPORTED ON 30 DECEMBER 2025 THAT THE PATIENT PRESENTED WITH GRADE 4+ DEGENERATIVE MITRAL REGURGITATION (MR) AND PROLAPSED POSTERIOR LEAFLET FOR A MITRACLIP PROCEDURE. DURING THE PREPARATION OF STEERABLE GUIDE CATHETER(SGC), AIR INGRESS THROUGH HEMOSTASIS VALVE WAS OBSERVED WHILE INSERTING THE DILATOR. THE SGC WAS REPLACED WITH ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE MR WAS REDUCED TO GRADE 1+ POST PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY OR ADVERSE PATIENT EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24162790 ↗
• InjuryJan 23, 2026Leak/Splash; Material Split, Cut or Torn

  IT WAS REPORTED ON (B)(6) 2025 THAT THE PATIENT PRESENTED WITH GRADE 4+ FUNCTIONAL MITRAL REGURGITATION (MR) AND ENLARGED ATRIUM FOR A MITRACLIP PROCEDURE. DURING THE PROCEDURE, THE STEERABLE GUIDE CATHETER(SGC) WAS ADVANCED INTO LEFT ATRIUM. ADDITIONAL ASPIRATION WAS NEEDED OUTSIDE THE INSTRUCTION FOR USE(IFU) AFTER A HOLE WAS NOTED IN THE HEMOSTATIC VALVE, WHICH RESULTED IN AIR INGRESS INTO THE ANATOMY. THE SGC WAS SUBSEQUENTLY REPLACED WITH A NEW DEVICE TO COMPLETE THE PROCEDURE. POST-PROCEDURE, MR WAS REDUCED TO GRADE 1+. THERE WAS NO CLINICALLY SIGNIFICANT DELAY OR ADVERSE EFFECT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24162713 ↗
• MalfunctionJan 22, 2026Positioning Failure

  IT WAS REPORTED ON (B)(6) 2025 THAT THE PATIENT PRESENTED WITH GRADE 4+ DEGENERATIVE MITRAL REGURGITATION (MR) AND PROLAPSED POSTERIOR LEAFLET FOR A MITRACLIP PROCEDURE. DURING THE PROCEDURE, DIFFICULTY WAS ENCOUNTERED WHILE GRASPING THE LEAFLETS. ONE MITRACLIP WAS SUCCESSFULLY IMPLANTED. THE MR WAS REDUCED TO GRADE 1+ POST PROCEDURE. ON (B)(6) 2025, FOLLOW UP REVEALED SINGLE LEAFLET DEVICE ATTACHMENT(SLDA) FROM THE POSTERIOR LEAFLET. PATIENT RETURNED SYMPTOMATIC WITH DYSPNEA AND ANGINA. THE MINUS KNOB WAS UNABLE TO STRAIGHTEN THE SLEEVE. PER THE PHYSICIAN, KNOB FUNCTIONALITY AFFECTED ADEQUATE GRASPING OF LEAFLETS WHICH MAY HAVE RESULTED IN SLDA. ANGINA WAS RESOLVED BY PERCUTANEOUS INTERVENTION. RECURRENT MR OF GRADE 4+ WAS REPORTED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24152959 ↗
• InjuryJan 9, 2026Adverse Event Without Identified Device or Use Problem

  N/A.

  Patient problems: Perforation

  MAUDE report 24027177 ↗
• MalfunctionJan 5, 2026Leak/Splash

  IT WAS REPORTED THAT ON (B)(6) 2025, A PATIENT PRESENTED WITH GRADE 4+ MITRAL REGURGITATION (MR), PROLAPSE OF THE ANTERIOR AND POSTERIOR LEAFLETS AT THE INNER COMMISSURE FOR A MITRACLIP PROCEDURE. DURING THE PROCEDURE, A MITRACLIP WAS SUCCESSFULLY IMPLANTED. WHILE RETRACTING THE STEERABLE GUIDE CATHETER (SGC) THE HEMOSTATIC VALVE FAILED TO CLOSE AND AIR ENTERED INTO THE HEMOSTATIC VALVE. THE VALVE WAS ASPIRATED AND SEALING COULD BE ACHIEVED WHILE THE TAIL END OF THE HEMOSTATIC VALVE WAS BLOCKED BY A FINGER. THE SGC WAS REMOVED FROM THE PATIENT AND A REPLACEMENT SGC WAS INSERTED WITHIN THE PATIENT AND AN ADDITIONAL MITRACLIP WAS IMPLANTED SUCCESSFULLY AND THE PROCEDURE WAS DISCONTINUED. THE FINAL MR WAS GRADE 2+. THERE WERE NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAYS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23958321 ↗
• InjuryDec 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  N/A.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 23924382 ↗
• InjuryDec 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2025 THAT THE PATIENT PRESENTED WITH GRADE 4+ FUNCTIONAL MITRAL REGURGITATION (MR) AND A RESTRICTED POSTERIOR LEAFLET FOR A MITRACLIP PROCEDURE. DURING THE PROCEDURE, ONE MITRACLIP WAS SUCCESSFULLY IMPLANTED AT ANTERIOR AND POSTERIOR LEAFLET 2(A2P2). DURING DEPLOYMENT OF SECOND MITRACLIP, AIR INGRESSION WAS OBSERVED FROM HEMOSTASIS VALVE OF STEERABLE GUIDE CATHETER (SGC). AIR EMBOLISM WAS FORMED IN THE BLOOD VESSEL. HYPOTENSION AND ELEVATION IN ST SEGMENT WAS OBSERVED ALONG WITH MYOCARDIAL INFRACTION. MEDICATION WAS ADMINISTERED TO CONTROL HYPOTENSION AND ST ELEVATION. THE MR WAS REDUCED TO GRADE 1+ POST PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY.

  Patient problems: Air Embolism; Low Blood Pressure/ Hypotension; Myocardial Infarction; Non specific EKG/ECG Changes

  MAUDE report 23855968 ↗
• MalfunctionNov 26, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED ON (B)(6) 2025 THAT THE PATIENT PRESENTED WITH GRADE 5 DEGENERATIVE MITRAL REGURGITATION (MR) FOR A MITRACLIP PROCEDURE. DURING THE STEERABLE GUIDE CATHETER(SGC) PREPARATION, A LEAK WAS OBSERVED IN HEMOSTATIC VALVE WHILE FLUSHING THE GUIDE. THE SGC WAS REPLACED WITH ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE MR WAS REDUCED TO GRADE <1 POST PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY OR ADVERSE PATIENT EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23657959 ↗
• InjuryNov 13, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT ON (B)(6) 2025, A PATIENT PRESENTED WITH GRADE MITRAL REGURGITATION FOR A MITRACLIP PROCEDURE. DURING THE PROCEDURE, A STEERABLE GUIDE CATHETER (SGC) WAS ADVANCED INTO THE LEFT ATRIUM WHEN AIR WAS IDENTIFIED AT THE PROXIMAL END OF THE SGC DURING NEGATIVE PRESSURE SUCTION WHILE WITHDRAWING THE DILATOR AND GUIDEWIRE. AT THIS TIME, THE PATIENT EXPERIENCED A MYOCARDIAL INFRACTION BELIEVED TO BE CAUSED BY A POTENTIAL AIR EMBOLISM. THE SGC WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS DISCONTINUED. THE FINAL MR WAS GRADE. THERE WERE NO CLINICALLY SIGNIFICANT DELAYS WERE REPORTED.

  Patient problems: Air Embolism

  MAUDE report 23547732 ↗
• InjurySep 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MITRACLIP PROCEDURE WAS PERFORMED TO TREAT DEGENERATIVE MITRAL REGURGITATION (MR) WITH A GRADE OF 4+. A STEERABLE GUIDE CATHETER (SGC) WAS INSERTED. HOWEVER, AFTER THE TIP OF THE SGC WAS INSERTED INTO THE LEFT ATRIUM (LA), THE BLOOD PRESSURE WENT DOWN VERY FAST. AFTER THE SGC WAS REMOVED, THE BLOOD PRESSURE RETURNED TO ALMOST BASELINE. IT WAS NOTED THAT THERE WAS POSSIBLY AN ATRIAL SEPTAL (AS) INJURY OR LEFT ATRIUM (LA) INJURY, BUT IT COULD NOT BE PROVEN. THEREFORE, THE SGC WAS REMOVED, AND THE PROCEDURE WAS DISCONTINUED. THERE WERE NO DEVICE ISSUES. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

  Patient problems: Low Blood Pressure/ Hypotension; Perforation

  MAUDE report 23161513 ↗
• MalfunctionSep 25, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT ON (B)(6) 2025, A PATIENT PRESENTED WITH GRADE 4+ MIXED MITRAL REGURGITATION (MR) FOR A MITRACLIP PROCEDURE. DURING PREPARATION OF THE STEERABLE GUIDE CATHETER (SGC) IT WAS IDENTIFIED THAT THE LIQUID COLUMN AT THE DISTAL END OF THE SGC COULD NOT BE MAINTAINED AND CONTINUOUSLY DROPPED. TROUBLESHOOTING WAS PERFORMED UNSUCCESSFULLY AND A NEW SGC WAS SELECTED. DURING THE PROCEDURE, THE REPLACEMENT SGC OPERATED AS INTENDED AND A MITRACLIP WAS SUCCESSFULLY IMPLANTED. THE FINAL MR WAS GRADE 1+. THERE WERE NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23143215 ↗
• MalfunctionSep 2, 2025Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT ON (B)(6) 2025, A PATIENT PRESENTED WITH GRADE 4 DEGENERATIVE MITRAL REGURGITATION (MR) FOR A MITRACLIP PROCEDURE. DURING THE PROCEDURE, IT WAS NOT POSSIBLE TO ADVANCE THE STEERABLE GUIDE CATHETER (SGC) DUE TO THE PATIENTS ANATOMY OF A CURVED FEMORAL VEIN AND A SIGNIFICANT AMOUNT OF LIGAMENTS. THE SGC WAS DAMAGED AND REMOVED FROM THE PATIENT. A REPLACEMENT SGC WAS SELECTED AND A MITRACLIP WAS IMPLANTED SUCCESSFULLY. THE FINAL MR WAS GRADE 1. THERE WERE NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAYS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22943954 ↗
• InjurySep 2, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT A MITRACLIP PROCEDURE WAS PERFORMED TO TREAT FUNCTIONAL MITRAL REGURGITATION (MR) WITH A GRADE OF 4+, THIN LEAFLETS, AND SUBOPTIMAL TRANSSEPTAL PUNCTURE. A STEERABLE GUIDE CATHETER (SGC) WAS INSERTED WITHOUT ISSUES. HOWEVER, DURING DILATOR REMOVAL OF THE SGC, A LEAK WAS OBSERVED, AND IMAGING REVEALED AIR IN THE LEFT CHAMBER. ASPIRATION WAS PERFORMED. A DECISION WAS MADE TO REMOVE AND REPLACE THE SGC. A NEW SGC WAS INSERTED, AND THE PROCEDURE WAS CONTINUED. ONE CLIP WAS IMPLANTED, REDUCING MR TO TRACE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

  Patient problems: Air Embolism

  MAUDE report 22938451 ↗
• MalfunctionAug 21, 2025No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT ON (B)(6) 2025, A MITRACLIP PROCEDURE WAS PERFORMED TO TREAT DEGENERATIVE MITRAL REGURGITATION (MR) AND PROLAPSED ANTERIOR LEAFLET. A MITRACLIP XTW INSERTED AND WAS DEPLOYED ON THE MITRAL VALVE, REDUCING MR TO TRACE. ON (B)(6) 2025, ONE WEEK POST IMPLANT, AN ECHOCARDIOGRAM WAS PERFORMED AND REVEALED RECURRENT MR WITH A GRADE OF 4+. IT WAS NOTED THAT THE CLIP REMAINED STABLE ON THE LEAFLETS. A MITRACLIP XTR WAS INSERTED AND DEPLOYED ON THE MITRAL VALVE, REDUCING MR TO A GRADE OF 1. THE STEERABLE GUIDE CATHETER (SGC) RETURNED AND REVEALED DAMAGE TO THE SOFT TIP AND BRADED SHAFT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22866235 ↗
• MalfunctionAug 21, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THIS WAS A MITRACLIP PROCEDURE TO TREAT MITRAL REGURGITATION (MR). DURING PREPARATION, AFTER FLUSHING THE STEERABLE GUIDE CATHETER (SGC), FUNCTIONAL TESTING WAS PREFORMED. IT WAS THEN NOTED THAT THE PLUS KNOB OF THE SGC WAS NOT FUNCTIONING AS INTENDED, HOWEVER THE MINUS KNOB WORKED AS INTENDED. THE SGC WAS REPLACED TO CONTINUE AND COMPLETE THE PROCEDURE. UPON DEVICE RETURN, IT WAS FOUND THAT THERE WAS A CABLE BREAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22861278 ↗