Guidestar™ Steerable Guiding Sheath D141103Recalls & reported problems

Summary

The FDA's MAUDE database contains 60 adverse event reports that list this exact device (DI 00885672010911), received between Sep 16, 2021 and Jan 10, 2025 — classified as 1 death, 22 injuries, 37 malfunctions.

The most frequently reported specific device problem is “Air/Gas in Device” (19 reports).

1 FDA recall record name this device's identifier.

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Dec 22, 2021Class IICompleted

   There is potential for separation between the threaded hub and threaded cap at the proximal end of the device.

   Z-0646-2022 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 60 reports, in the reporter's own words as published by the FDA.

• InjuryJan 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEMATOME PUNCTURE SITE. ADDITIONAL INFORMATION 08/JAN/2024 DURING ATRIAL FIBRILLATION PROCEDURE, HEMATOME PUNCTURE SITE. PATIENT IS RECOVERING, RESOLVING. DEVICE IS ASSOCIATED WITH SECURE STUDY. (B)(6), NAME OF CONTACT. A FOLLOW UP ACTIVITY WILL BE INITIATED FOR THE REST OF THE QUESTIONS. WE WILL NOTIFY IF ADDITIONAL INFORMATION IS RECEIVED. NOT KNOWN IF DEVICE WILL BE RETURNED FOR EVALUATION, CHECKING WITH SALES REPRESENTATIVE. BEING SUBMITTED FOR ADMINISTRATION PURPOSES 1(B)(4).

  Patient problems: Pseudoaneurysm

  MAUDE report 21123577 ↗
• DeathNov 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SERIOUSNESS CRITERIA. DEATH: YES. LIFE-THREATENING ILLNESS OR INJURY: NO. A PERMANENT IMPAIRMENT OF A BODY STRUCTURE OR A BODY FUNCTION: NO IN-PATIENT HOSPITALIZATION OR PROLONGATION OF EXISTING HOSPITALIZATION: YES ADMISSION DATE: (B)(6) 2024 DISCHARGE DATE: (B)(6) 2024 MEDICAL OR SURGICAL INTERVENTION TO PREVENT LIFE-THREATENING ILLNESS OR INJURY, OR PERMANENT IMPAIRMENT TO A BODY STRUCTURE OR A BODY FUNCTION: NO CHRONIC DISEASE: NO FETAL DISTRESS, FETAL DEATH, A CONGENITAL ABNORMALITY, OR BIRTH DEFECT INCLUDING PHYSICAL OR MENTAL IMPAIRMENT: NO. 04/NOV/2024 ADDITIONAL INFORMATION: PATIENT (B)(6) WAS TREATED BY ABLATION PROCEDURE ON (B)(6) 2024, THERE WAS NO DELAY IN PROCEDURE, AND NO ADDITIONAL MEDICAL INTERVENTION DURING PROCEDURE WAS NOTED. PATIENT WAS DISCHARGED AFTER PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT'S HEALTH STATUS WAS NORMAL. THE INVESTIGATIONAL DEVICES (CABLE, CATHETER, GENERATOR, AND SHEATH) WERE USED ONLY ONCE. IN ADDITION TO THE INVESTIGATIONAL CATHETER, A MAPPING CATHETER WAS ALSO USED. THE DEVICE WAS USED AS PER PROTOCOL, AND NO DEVICE DEFICIENCY WAS REPORTED. AFTER NORMAL USE, SINCE THERE WAS NO DEVICE DEFICIENCY REPORTED, THE SHEATH WAS DESTROYED AT SIT

  Patient problems: Cardiac Arrest

  MAUDE report 20758894 ↗
• MalfunctionSep 3, 2024Break; Break

  THE CUSTOMER INITIALLY REPORTED THAT DURING AN AFIB PAROX PROCEDURE THE PHYSICIAN FELT AND HEARD THE BREAK OF THE GUIDESTAR. AFTER SOME MANIPULATIONS IN THE HEART, THE GUIDESTAR BROKE. THE GUIDESTAR WAS CHANGED, AND THE PROCEDURE WAS FINISHED. THERE WAS ONLY A 5-MINUTE DELAY TO CHANGE THE GUIDESTAR. ON (B)(6) 2024 THE CUSTOMER REPORTED THAT THE ABLATIONS HAD ALREADY BEEN CARRIED OUT BEFORE THE GUIDESTAR BROKE. IT BROKE WHEN THE DOCTOR WAS MOVING INTO ANOTHER VEIN. THE FAM WAS DONE COMPLETELY. IT WAS ALSO REPORTED THAT THE DEVICE BROKE DURING USE WITHIN THE CHAMBERS OF THE HEART (LEFT ATRIUM).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20127628 ↗
• InjuryJun 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED BLEEDING IN THE RIGHT GROIN. PRODUCT NOT RETURNING. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19497947 ↗
• InjuryMay 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THE PATIENT DEVELOPED A HEMATOMA IN THE RIGHT GROIN SOMETIME DURING OR AFTER AN ATRIAL FIBRILLATION (AFIB) PROCEDURE. THE PATIENT RECOVERED AND ISSUE RESOLVED. PRODUCT NOT RETURNING AS THERE IS NO PRODUCT DEFECT REPORTED.

  Patient problems: Hematoma

  MAUDE report 19372422 ↗
• InjuryOct 24, 2023Air/Gas in Device; Air/Gas in Device

  THE CUSTOMER REPORTED THE GUIDESTAR WAS FULL OF BUBBLES; THE HEMOSTATIC VALVE DID NOT WORK PROPERLY. THE PATIENT EXPERIENCED BUBBLES IN RIGHT CORONARY. ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY; THEREFORE, A HEMODYNAMIC PROCEDURE WAS NECESSARY TO REMOVE BUBBLES. THIS RESULTED IN A PROCEDURE DELAY OF 45 MINUTES. THE PROCEDURE WAS NOT SUCCESSFULLY COMPLETED.

  Patient problems: Air Embolism

  MAUDE report 17995749 ↗
• MalfunctionSep 29, 2023Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component

  PROCEDURE - PRE-CLINICAL STUDY - HELIOS PFA DVT STUDY. IT WAS REPORTED THAT WHEN THE SHEATH WAS IN THE LEFT ATRIUM AND A CATHETER WAS BEING ADVANCED INTO THE SHEATH, THE SIDE PORT OF THE SHEATH BROKE OFF AND CAUSED BLOOD TO LEAK BACK. THEY REPLACED THE SHEATH AND THE PROCEDURE CONTINUED. NO REPLACEMENT SHEATH WAS REQUESTED. DOCUMENTATION REQUESTED FOR THE SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17844455 ↗
• InjurySep 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED:: 1. DURING THE CASE, AFTER RF APPLICATION AROUND THE LIPV, CHANGE OF THE PATIENT EKG, TRANSLATING SIGNS OF HEART ATTACK OR CORONARY SPASMS (UNCERTAIN REASON) 2. STANDARDIZATION OF THE EKG AFTER 10 MINUTES. THE ABLATION WAS FINALIZED WITHOUT ANOTHER INCIDENT. 3. AROUND 1H 30 LATER, PATIENT PRESENTED STROKE SYMPTOMS. 4. NEUROLOGICAL SYMPTOMS HAVE DISAPPEARED AT THE END OF THE DAY. ADDITIONAL INFORMATION: DURING THE CASE, ALL DEVICES HAVE BEEN USED ACCORDING TO USAGE INSTRUCTIONS: ABLATION AT 15W DURING 45SEC FOR ANTERIOR PART AND 15SEC FOR THE POSTERIOR PART IN TOTAL, PATIENT RECEIVED 4 RF APPLICATION FOR A TOTAL OF 3MINUTES OF RADIOFREQUENCY. ACT MEASURED AT 365 DURING THE CASE. AN EXTERNAL SHOCK WAS PERFORMED AT THE END OF THE CASE TO RESTORE SINUS RHYTHM. FOLLOWING THE CASE, PATIENT HAD ADDITIONAL EXAM: CORONARY ANGIOGRAPHY WHICH APPEARED NORMAL CEREBRAL IRM: LESION WERE FOUND CONFIRMING THE STROKE DIAGNOSTIC. SUBMITTING FOR ADMINISTRATIVE PURPOSES - ADVERSE EVENT.

  Patient problems: Cardiac Arrest; Non specific EKG/ECG Changes; Stroke/CVA

  MAUDE report 17711481 ↗
• InjuryAug 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICES USED DURING THE CASE: - CARTO3 SYSTEM SN: (B)(6) / V7.2.40.250 - NGEN GENERATOR SN: (B)(6) - NGEN PUMP SN: (B)(6). THE CALLER CONFIRMED THAT NO OTHER BIOSENSE WEBSTER DEVICES HAVE BEEN USED. CATHETER USED DURING THE CASE: - HELIOS STAR BALLOON - GUIDES STAR - LASSO STAR PLEASE NOTE THAT ALL CATHETERS HAVE BEEN DISCARDED SO THE CALLER COULDN'T PROVIDE ANY LOT NUMBERS. THE BWI REPRESENTATIVE CONFIRMED THAT THEY DIDN'T HAVE ANY ISSUE ON THE SYSTEM, BUT IT WAS REPORTED THAT THE PATIENT HAD A PHRENIC NERVE PALSY DURING THE ABLATION OF THE RIGHT PULMONARY VEIN. THE PATIENT IS ALIVE. PROCEDURE HAS BEEN COMPLETED. NO DELAY. TYPE OF PROCEDURE: PULMONARY VEIN ISOLATION (PVI). NO FURTHER ACTION NEEDED; THE CALLER JUST WANTED TO REPORT THE ADVERSE EVENT.

  Patient problems: Nerve Damage

  MAUDE report 17434512 ↗
• MalfunctionAug 1, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITIONAL INFORMATION RECEIVED 08/11/2023: THE CUSTOMER STATED ONE OF THE ELECTRODES WHICH DELIVERS RADIOFREQUENCY WAS DETACHED FROM THE BALLOON CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17432480 ↗
• InjuryJul 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED PATIENT HAS BLEEDING GROIN. THERE IS NO REPORTED PERFORMANCE ISSUE ASSOCIATED WITH THE GUIDESTAR. THE PATIENT IS A 72-YEAR-OLD MALE, THAT IS PART OF A POST-MARKET CLINICAL STUDY NAMED (B)(4) SECURE. DURING AN ATRIAL FIBRILLATION PROCEDURE, THE PATIENT STARTING BLEEDING. IT IS UNKNOWN IF ANY BLOOD WAS LOST, AND WHEN THE BLEEDING OCCURRED. THE BLEED WAS RESOLVED WITH AN INTERVENTION WITH COMPRESSION BANDAGE AND STERI-STRIPS. THE PATIENT'S OUTCOME WAS REPORTED AS "RECOVERED/RESOLVED." THERE WAS NO MEDICAL OR SURGICAL INTERVENTION TO PREVENT LIFE-THREATENING ILLNESS OR INJURY OR PERMANENT IMPAIRMENT TO A BODY STRUCTURE OR A BODY FUNCTION. HOWEVER, THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2023 AND DISCHARGED ON (B)(6) 2023. IT WAS REPORTED, IN THE OPINION OF THE INVESTIGATOR IN ACCORDANCE WITH THE LIST OF EXPECTED EVENTS IN THE INSTRUCTIONS FOR USE, THIS ADVERSE EVENT WAS EXPECTED AND, OR ANTICIPATED. CUSTOMER MADE MULTIPLE ATTEMPTS TO OBTAIN LOT NUMBER AND TO GET THE DEVICE BACK, BUT ATTEMPTS WERE NOT SUCCESSFUL.THE CUSTOMER REPORTED THE ROOT CAUSE OF REPORTING THIS EVENT APPROXIMATELY 5 MONTHS AFTER EVENT, WAS DUE TO HUMAN ERROR BY THE TEAM IN CHARGE OF SEN

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17417438 ↗
• MalfunctionMay 12, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING PVI PROCEDURE SHEATH STARTED LEAKING THROUGH VALVE. IT WAS REPLACED AND PROCEDURE CONTINUED. THERE WAS 10 MIN DELAY REPORTED. NO PATIENT SIDE EFFECTS WERE REPORTED. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16921136 ↗
• InjuryMay 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER PROVIDED ADDITIONAL EVENT INFORMATION FOR THE REPORTED HEMATOMA IN GROIN; THERE WAS NO INJURY, NO HOSPITALIZATION, AND NO ADVERSE PATIENT EFFECT. PATIENT OUTCOME STATES RECOVERED AND RESOLVED. ADDITIONALLY, IT WAS REPORTED THERE WAS NO PRODUCT PERFORMANCE ISSUE. THE DEVICE WILL NOT BE RETURNED AND CUSTOMER WAS NOT ABLE TO OBTAIN LOT NUMBER.

  Patient problems: Hematoma

  MAUDE report 16912736 ↗
• InjuryMay 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED THAT PATIENT HAD PSEUDO-ANEURYSM RIGHT GROIN. NO PRODUCT MALFUNCTION REPORTED BY CUSTOMER .NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Aneurysm

  MAUDE report 16872319 ↗
• InjuryMay 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED BLEEDING IN RIGHT GROIN. INTERVENTION SPECIFIES A NEW BANDAGE APPLIED. PATIENT OUTCOME STATES RECOVERING. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16870485 ↗
• MalfunctionMay 2, 2023Air/Gas in Device; Air/Gas in Device

  DURING A HELIOSTAR PROCEDURE FOR PULMONARY VEIN ISOLATION, THE SEPTUM WAS PUNCTURED WITH AN 8.5FR BIOSENSE WEBSTER CARDIAGUIDE SHEATH. SUBSEQUENTLY, THE 14FR BIOSENSE WEBSTER GUIDESTAR SHEATH WAS PASSED INTO THE LEFT ATRIUM. CONTRAST WAS USED TO VISUALIZE THE LEFT SUPERIOR PULMONARY VEIN VIA A PIG TAIL CATHETER. AFTER IMAGING, A PROMINENT ST ELEVATION WAS NOTED. BECAUSE OF THE ST ELEVATION, THE PATIENT WAS IMMEDIATELY GIVEN NITRO AND VOLUME. DIRECT ANGIOGRAPHY REVEALED AN UNDETERMINED AMOUNT OF AIR IN THE RIGHT CORONARY ARTERY AND AORTIC ARCH (A. ASCENDERS). THE AIR WAS ASPIRATED AS BEST AS POSSIBLE. THE PATIENT WAS THEN TAKEN TO A COMPUTER TOMOGRAPH FOR FURTHER DIAGNOSIS. AT THE TIME OF THE PROCEDURE NO NEUROLOGIC SYMPTOMS WERE DETERMINED. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16856472 ↗
• MalfunctionMar 23, 2023Air/Gas in Device; Air/Gas in Device

  UNUSUALLY, THE SHEATH DREW A LOT OF AIR. AFTER A NUMBER OF ASPIRATIONS, WE DECIDED TO CHANGE THE SHEATH BECAUSE THE RISK FOR THE PATIENT WAS TOO HIGH. THERE WAS A 3 MINUTE DELAY IN THE PROCEDURE TO OBTAIN A NEW SHEATH WHICH RESOLVED THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16599568 ↗
• MalfunctionMar 16, 2023Air/Gas in Device; Air/Gas in Device

  UNUSUALLY, THE SHEATH DREW A LOT OF AIR. WE HAD SEVERAL ASPIRATION OF AIR AND THEN WE DIDN'T HAVE ANYMORE AIR. IT WAS REPORTED THERE WAS A ONE MINUTE DELAY IN PROCEDURE. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16560098 ↗
• MalfunctionMar 8, 2023Air/Gas in Device; Air/Gas in Device

  ADDITIONAL INFORMATION, PROCEDURE WAS COMPLETED SUCCESSFULLY USING THE SAME DEVICE. NO HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16506139 ↗
• MalfunctionMar 6, 2023Use of Incorrect Control/Treatment Settings; Use of Incorrect Control/Treatment Settings

  THE PHYSICIAN COMPLAINED THAT THE LENGTH OF THE GUIDESTAR DILATOR IS 3 CM SMALLER THAN THE ONE FOR VIZIGO. HE REPORTED THAT IT IS SUPER DANGEROUS IF ONE DOES TRANSEPTAL PUNCTURE WITH GUIDESTAR SHEATH. ON THE SALES REP SIDE, IT IS WRITTEN IN NONE OF OUR TRAINING! ONLY BY COMPARING SIDE BY SIDE THE SHEATHS BOXES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16489689 ↗
• MalfunctionFeb 23, 2023Air/Gas in Device; Air/Gas in Device

  ADDITIONAL INFORMATION: DURING ATRIAL FIBRILLATION ABLATION, WHILE PULLING THE SHEATH OUT OF THE PATIENT'S LEFT ATRIUM, ASPIRATION OF AIR BUBBLES OCCURRED. THE PATIENT DID NOT EXPERIENCE AN AIR EMBOLISM, AND THERE WAS NO HARM TO THE PATIENT. NO MEDICAL INTERVENTION OR ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED, HOWEVER, THERE WAS A PROCEDURE DELAY OF LESS THAN 30 MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A COMPETITOR'S SHEATH AND CATHETER. NO FORCE WAS APPLIED, AND PATIENT'S ANATOMY WAS NORMAL. NO PICTURES ARE AVAILABLE. THE DEVICE WILL NOT BE RETURNED, AS IT WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16427549 ↗
• InjuryFeb 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED DURING AN AFIB PROCEDURE, A PERICARDIAL FLUID WAS OBSERVED. AN ADDITIONAL SURGERY FOR LESS THAN ONE HOUR WAS REQUIRED FOR A BLOOD TRANSFUSION. ADJUVANT DRUG THERAPY BY ANESTHESIA AND PRESSURE MONITORING. PERICARDIOCENTESIS WAS PERFORMED. PATIENT WAS STABLE AND UNDER CONTROL. ALONG WITH THIS GUIDESTAR, THESE ADDITIONAL DEVICES WERE USED IN THIS PROCEDURE HELIOSTAR, LASSOSTAR, SWARTZ SHEATH LAMP AND FOUR BRK NEEDLES. IT WAS REPORTED ALL DEVICES USED IN THIS PROCEDURE WERE DISCARDED.

  Patient problems: Pericardial Effusion

  MAUDE report 16373179 ↗
• InjuryJan 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS NOT POSSIBLE TO OPEN THE BALLOON CATHETER FULLY (INFLATION INDEX <0,7), CHANGING THE BALLOON WAS NECESSARY. AFTER CHANGING THE BALLOON PATIENT HAD ST ELEVATIONS IN THE BODY SURFACE ECG: APPARENTLY WITH THE CHANGING SOME AIR WAS INTRODUCED IN THE PATIENT. THERE WAS A 20 MINUTE DELAY IN THE PROCEDURE. AFTER THE PROCEDURE, WHEN THE PATIENT WAS NOT MORE UNDER ANESTHESIA, HE COULD NOT MOVE HIS ONE HAND/ARM AND HAD SPEECH DISORDERS. THE NEUROLOGIST ORDERED A CT SCAN OF THE HEAD. NOTHING WAS FOUND. AFTER A WHILE THE SYMPTOMS GOT BETTER. THE NEXT DAY THE PATIENT RECEIVED AN MRI OF THE HEAD AND SMALL AIR EMBOLISMS WERE FOUND.

  Patient problems: Air Embolism

  MAUDE report 16084045 ↗
• InjuryDec 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD HEART LEAK IN THE LAA AND DURING THE OPERATION PERICARDIAL EFFUSION OCCURRED. MEDICAL INTERVENTION WAS REQUIRED TO STOP THE HEART FROM BLEEDING. THE CASE WAS CANCELLED. PER THE PHYSICIAN, THE PERICARDIAL EFFUSION WAS DUE TO THE PROCEDURE AND PATIENT CONDITION. IT WAS REPORTED THE PATIENT'S OUTCOME HAS IMPROVED. NO DEVICE PROBLEM REPORTED.

  Patient problems: Cardiac Perforation; Hemorrhage/Blood Loss/Bleeding; Pericardial Effusion

  MAUDE report 16055788 ↗
• MalfunctionDec 19, 2022Fluid/Blood Leak; Fluid/Blood Leak

  THE GUIDESTAR SHEATH DRIPPED AT THE FLUSHING CONNECTION AT THE WHITE PART OF THE HANDLE. THE PHYSICIAN DIDN'T WANT TO CHANGE TO ANOTHER ONE DUE TO AIR MANAGEMENT. THE PROCEDURE WAS ENDED SUCCESSFULLY. SO THERE WAS NO DAMAGE AND CONSEQUENCES CAUSED TO THE PATIENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16003918 ↗