OptiCross™ HD H74939352050Recalls & reported problems

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 00191506035419), received between Jul 15, 2024 and Sep 25, 2026 — classified as 11 injuries, 29 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (17 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 40 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Entrapment of Device; Material Deformation

  It was reported that a catheter issue occurred.The 85% stenosed target lesion was located in the mildly calcified and mildly tortuous mid right coronary artery (RCA). The OptiCross HD imaging catheter was selected for intravascular ultrasound (IVUS) examination of the target lesion. The IVUS run was completed without issue. During catheter removal, resistance was encountered and the guidewire was pulled out with the catheter. Upon inspection, the catheter was noted to be torn or broken, and the guidewire exhibited a sharp U bend. The procedure was completed with another of the same device. The patient condition following the procedure was stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50893175 ↗
• MalfunctionJul 7, 2026Leak/Splash; Air/Gas in Device

  IT WAS REPORTED THAT CATHETER ISSUE OCCURRED. AN OPTICROSS HD IMAGING CATHETER WAS SELECTED FOR ULTRASOUND EXAMINATION FOR THE TARGET LESION. DURING PREPARATION, A LEAK WAS NOTICED ON THE FLUSHING TUBE WHICH PREVENTED PROPER AIR REMOVAL. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PATIENT REMAINED STABLE AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25740374 ↗
• InjuryApr 9, 2026Air/Gas in Device

  IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE PATIENT WAS NOT SEDATED. THE OPTICROSS HD IMAGING CATHETER WAS ADVANCED FOR INTRAVASCULAR ULTRASOUND (IVUS) EXAMINATION OF THE TARGET LESION. THE IVUS WAS STOPPED IN THE MIDDLE OF THE RUN AND WHEN RESTARTED, AIR WAS INTRODUCED THROUGH THE CATHETER INTO THE PATIENT. AIR WAS INCREASED TO 100% AND THROMBECTOMY PERFORMED. THE PROCEDURE WAS NOT COMPLETED. THE PATIENT IS EXPECTED TO FULLY RECOVER.

  Patient problems: Air Embolism

  MAUDE report 24835508 ↗
• MalfunctionApr 1, 2026Difficult to Flush; Air/Gas in Device

  IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE OPTICROSS HD IMAGING CATHETER WAS SELECTED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION. DURING PREPARATION, THE CATHETER COULD NOT BE FLUSHED, AND AIR WAS OBSERVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24756797 ↗
• MalfunctionFeb 17, 2026Material Deformation

  IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. AN OPTICROSS HD WAS ADVANCED FOR AN ULTRASOUND EXAMINATION OF THE TARGET LESION. DURING THE PROCEDURE, THE FIRST ONE SNAPPED WHEN ATTEMPTING TO USE THE SECOND. THERE WAS NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24366175 ↗
• MalfunctionFeb 11, 2026No Display/Image; Air/Gas in Device

  IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED DISTAL LEFT ANTERIOR DESCENDING ARTERY. THE OPTICROSS HD IMAGING CATHETER WAS SELECTED FOR INTRAVASCULAR ULTRASOUND EXAMINATION. DURING THE PROCEDURE, BLACKOUT ISSUES WERE ENCOUNTERED WITH THE IVUS CATHETER, WHICH DISRUPTED IMAGING AND CREATED CHALLENGES DURING THE PROCEDURE. DESPITE REPEATED USER ATTEMPTS TO ELIMINATE AIR BUBBLES THROUGH MULTIPLE FLUSHING, THE ISSUE PERSISTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PATIENTS CONDITION WAS GOOD, AND NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24318265 ↗
• MalfunctionFeb 3, 2026Difficult to Flush; Nonstandard Device; Air/Gas in Device

  IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE CORONARY ARTERY. THE OPTICROSS HD IMAGING CATHETER WAS SELECTED FOR INTRAVASCULAR ULTRASOUND EXAMINATION. DURING PREPARATION, THE CATHETER COULD NOT BE FLUSHED, AND AIR WAS NOTED OUTSIDE THE BODY. MULTIPLE FLUSHING ATTEMPTS WERE UNSUCCESSFUL, AND THE CATHETER DID NOT ENTER THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PATIENT FULLY RECOVERED AND NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24250609 ↗
• MalfunctionJan 7, 2026Difficult to Flush; Nonstandard Device; Air/Gas in Device

  IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE OPTICROSS HD IMAGING CATHETER WAS SELECTED FOR INTRAVASCULAR ULTRASOUND EXAMINATION. DURING PREPARATION, THE IVUS CATHETER WOULD NOT FLUSH; THE TUBING BALLOONED OUT, AND BUBBLES WERE NOTED WITHIN THE TUBING. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATIVE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23990172 ↗
• MalfunctionJan 5, 2026Nonstandard Device; Detachment of Device or Device Component

  IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. AN OPTICROSS HD IMAGING CATHETER WAS SELECTED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION. DURING THE PROCEDURE, THE CATHETER WAS SEPARATED FROM THE SHEATH. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23968890 ↗
• MalfunctionJan 5, 2026Entrapment of Device

  IT WAS REPORTED THAT CATHETER ISSUE OCCURRED. AN OPTICROSS HD IMAGING CATHETER WAS SELECTED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION. DURING ADVANCEMENT THE PHYSICIAN WAS USING A WIGGLE WIRE, AND THE WIRE BECAME WRAPPED AROUND THE CATHETER WHILE THE IMAGING MODE WAS ON. THE PHYSICIAN WAS ABLE TO PULL EVERYTHING OUT FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23968873 ↗
• MalfunctionDec 29, 2025Poor Quality Image; Nonstandard Device; Poor Quality Image; Nonstandard Device

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 04 DEC 2025. IT WAS REPORTED THAT VISUALIZATION ISSUES OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS AND MODERATELY CALCIFIED VESSEL. THE OPTICROSS HD IMAGING CATHETER WAS ADVANCED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION; BUT THE IMAGE EXHIBITED NON-UNIFORM ROTATIONAL DISTORTION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE CATHETER WAS TWISTED AND THAT THE IMAGING WINDOW EXHIBITED RIPPLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23910920 ↗
• InjuryDec 18, 2025Nonstandard Device; Detachment of Device or Device Component; Nonstandard Device; Detachment of Device or Device Component

  IT WAS REPORTED THAT CATHETER ISSUE OCCURRED. THE TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS VESSEL. AN OPTICROSS HD IMAGING CATHETER WAS SELECTED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION. DURING THE PROCEDURE, THE TIP OF THE IVUS CATHETER BECAME DETACHED IN THE TORTUOUS ANATOMY AFTER MANIPULATION. A SNARE WAS USED TO RETRIEVE THE DISLODGED SECTION. ALL WAS REMOVED WITHOUT PATIENT ISSUE. THE PROCEDURE WAS COMPLETED USING ALTERNATIVE METHOD. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23845774 ↗
• MalfunctionDec 11, 2025Entrapment of Device; Nonstandard Device; Entrapment of Device; Nonstandard Device

  IT WAS REPORTED THAT CATHETER ISSUE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED VESSEL. AN OPTICROSS HD IMAGING CATHETER WAS SELECTED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION. DURING THE PROCEDURE, THE CATHETER GOT STUCK TO THE WIRE AND COULD NOT ADVANCE FURTHER INTO THE VESSEL. BOTH DEVICES WERE REMOVED AS ONE UNIT. AN ALTERNATIVE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO COMPLICATIONS AND THE PATIENT FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23782595 ↗
• MalfunctionDec 10, 2025Entrapment of Device; Nonstandard Device; Entrapment of Device; Nonstandard Device

  IT WAS REPORTED THAT CATHETER ISSUE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED CORONARY ARTERY. AN OPTICROSS HD IMAGING CATHETER WAS SELECTED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION. DURING THE PROCEDURE, THE GUIDEWIRE BECAME TRAPPED IN THE CATHETER AND BOTH WERE REMOVED TOGETHER. THE GUIDEWIRE WAS ABLE TO BE SEPARATED FROM THE CATHETER OUTSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED USING ANOTHER METHOD WITHOUT ANY PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23766441 ↗
• MalfunctionDec 3, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. AN OPTICROSS HD CATHETER WAS SELECTED FOR THE ULTRASOUND EXAMINATION OF THE TARGET LESION. DURING PROCEDURE DETACHMENT WAS NOTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23704731 ↗
• MalfunctionDec 2, 2025No Display/Image; Failure to Advance; Detachment of Device or Device Component; No Display/Image; Failure to Advance; Detachment of Device or Device Component

  IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. AN OPTICROSS HD CATHETER WAS ADVANCED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION. HOWEVER, IT WAS NOTED UNDER FLUOROSCOPY, THAT THE DISTAL TIP WAS FRACTURED. NO IMAGES WERE TAKEN, AND THE DEVICE WAS REMOVED FROM THE PATIENT WITHOUT HARM. THE PROCEDURE WAS COMPLETED USING ANOTHER CATHETER. THERE WERE NO PATIENT COMPLICATIONS. IT WAS FURTHER REPORTED THAT THE DEVICE DID NOT CROSS THE LESION AND WAS REMOVED AS A WHOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23698196 ↗
• InjuryNov 18, 2025Entrapment of Device; Nonstandard Device; Detachment of Device or Device Component; Physical Resistance/Sticking; Entrapment of Device; Nonstandard Device; Detachment of Device or Device Component; Physical Resistance/Sticking

  IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE OPTICROSS HD IMAGING CATHETER WAS SELECTED FOR ULTRASOUND EXAMINATION IN THE RIGHT CORONARY ARTERY (RCA). THE PHYSICIAN ATTEMPTED TO PERFORM INTRAVASCULAR ULTRASOUND WITH A 5 MM CATHETER. IT WAS DIFFICULT TO ADVANCE DUE TO THE TORTUOSITY IN THE MID RCA, BUT THE CATHETER WAS ADVANCED TO THE LESION AND IVUS WAS PERFORMED. AS THE PHYSICIAN TRIED TO REMOVE THE CATHETER, IT BECAME TANGLED IN THE TORTUOSITY IN THE MID RCA. THE CATHETER ITSELF CAME OUT, BUT THE HYPOTUBE THAT THE CATHETER WAS ADVANCED THROUGH SHEARED OFF ON THE WIRE IN THE MID RCA. THE PHYSICIAN WAS ABLE TO SNARE IT OUT USING A 4 - 8 MM SNARE OVER THE WIRE, BUT ALL OF THE EQUIPMENT INCLUDING THE GUIDE CATHETER AND WIGGLE WIRE HAD TO BE REMOVED. THE PHYSICIAN CONFIRMED THAT THE TIP OF THE CATHETER WAS COMPLETELY REMOVED FROM THE BODY. THE PROCEDURE WAS COMPLETED USING ORIGINAL METHOD. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23586027 ↗
• MalfunctionNov 13, 2025Entrapment of Device; Physical Resistance/Sticking; Entrapment of Device; Physical Resistance/Sticking

  IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. AN OPTICROSS HD IMAGING CATHETER WAS SELECTED FOR INTRAVASCULAR ULTRASOUND (IVUS) EXAMINATION OF THE TARGET LESION. THE CATHETER WAS USED MULTIPLE TIMES. AFTER POST-STENTING, THE PHYSICIAN WANTED TO USE IVUS, HOWEVER THE CATHETER TIP WAS STUCK AT THE STENT. THE CATHETER WAS REMOVED, BUT WITH DIFFICULTY. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23541656 ↗
• MalfunctionOct 15, 2025Poor Quality Image; Nonstandard Device; Failure to Advance; Poor Quality Image; Nonstandard Device; Failure to Advance

  IT WAS REPORTED THAT A DEVICE ISSUE OCCURRED RESULTING IN AN ABORTED PROCEDURE. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING (LAD) ARTERY. AN OPTICROSS HD IMAGING CATHETER WAS SELECTED FOR USE IN THE ULTRASOUND EXAMINATION. DURING THE PROCEDURE, THERE WAS DIFFICULTY INTERPRETING THE IMAGE DUE TO IMAGE QUALITY ISSUES AND CROSSING WAS NOT POSSIBLE DUE TO CALCIFICATION. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WAS NO PATIENT COMPLICATIONS REPORTED, AND THE PATIENT WAS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23304328 ↗
• MalfunctionOct 15, 2025Poor Quality Image; Failure to Advance; Poor Quality Image; Failure to Advance

  IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED, RESULTING IN AN ABORTED PROCEDURE. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED DISTAL LEFT ANTERIOR DESCENDING ARTERY. THE OPTICROSS HD IMAGING CATHETER WAS ADVANCED FOR INTRAVASCULAR ULTRASOUND (IVUS) EXAMINATION OF THE TARGET LESION. DURING THE PROCEDURE, THERE WAS DIFFICULTY INTERPRETING THE IMAGE DUE TO IMAGING ISSUES AND FAILURE TO CROSS THE LESION BECAUSE OF CALCIFICATION. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT AND WAS RESCHEDULED. THE PATIENTS CONDITION WAS FINE, AND NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23303676 ↗
• MalfunctionAug 7, 2025Entrapment of Device; Material Deformation; Entrapment of Device; Material Deformation

  IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE APPROXIMATELY 70 - 80% STENOSED TARGET LESION WAS LOCATED IN A VERY TORTUOUS AND MODERATELY CALCIFIED RIGHT CORONARY ARTERY (RCA). A 5FR OPTICROSS HD IMAGING CATHETER WAS SELECTED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION POST STENT PLACEMENT. DURING THE PROCEDURE, THE CATHETER BECAME KINKED AND COULD NOT BE REMOVED OVER THE NON-BOSTON SCIENTIFIC (NON-BSC) GUIDEWIRE. BOTH THE CATHETER AND THE WIRE WERE REMOVED TOGETHER, AND THE PHYSICIAN APPLIED SIGNIFICANT FORCE TO EXTRACT THEM FROM THE RADIAL SHEATH. THE PROCEDURE WAS COMPLETED USING AN ALTERNATIVE METHOD, AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22743402 ↗
• MalfunctionJul 31, 2025Entrapment of Device; Material Deformation; Entrapment of Device; Material Deformation

  IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE TARGET LESION WAS LOCATED IN THE CORONARY ARTERY. AN OPTICROSS HD IMAGING CATHETER WAS SELECTED FOR THE ULTRASOUND EXAMINATION OF THE TARGET LESION. DURING WITHDRAWAL, THE CATHETER KINKED AND COILED AROUND THE WIRE. THE DEVICE WAS REMOVED FROM THE BODY ALONG WITH THE WIRE AS A SINGLE PIECE. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE METHOD. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22674119 ↗
• MalfunctionJun 26, 2025Entrapment of Device; Physical Resistance/Sticking; Entrapment of Device; Physical Resistance/Sticking

  IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE TARGET LESION WAS LOCATED IN A TORTUOUS AND CALCIFIED CORONARY ARTERY. AN OPTICROSS IMAGING CATHETER WAS SELECTED FOR INTRAVASCULAR ULTRASOUND (IVUS) EXAMINATION OF THE TARGET LESION. DURING THE PROCEDURE, AFTER COMPLETING THE POST-STENT IVUS RUN, THE OPTICROSS IMAGING CATHETER APPEARED TO BE STUCK ON THE WIRE. EVERYTHING WAS ABLE TO BE REMOVED WHEN REMOVED TOGETHER, HOWEVER THE CATHETER ITSELF COULD NOT BE REMOVED OVER THE WIRE. THE PROCEDURE WAS COMPLETED USING ORIGINAL METHOD. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22342604 ↗
• MalfunctionJun 12, 2025Entrapment of Device; Material Integrity Problem; Entrapment of Device; Material Integrity Problem

  IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING (LAD) ARTERY. AN OPTICROSS HD IMAGING CATHETER WAS SELECTED FOR ULTRASOUND EXAMINATION OF THE LESION. DURING THE PROCEDURE, THE DEVICE GOT STUCK AT THE FAR END OF THE STENT AND WAS DEFORMED AFTER BEING REMOVED FROM THE BLOOD VESSEL. THE CATHETER WAS EXTRACTED BY MOVING IT BACK AND FORTH TO FREE IT, THEN REMOVING IT DIRECTLY AFTER SEPARATING IT WHERE IT WAS STUCK. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. THE PATIENT CONDITION WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22193740 ↗
• InjuryMay 20, 2025Device-Device Incompatibility; Material Integrity Problem; Device-Device Incompatibility; Material Integrity Problem

  IT WAS REPORTED THAT CATHETER ISSUE OCCURRED. AN OPTICROSS HD IMAGING CATHETER WAS SELECTED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION. DURING THE PROCEDURE, THE INTRAVASCULAR ULTRASOUND (IVUS) CATHETER WAS INSERTED POST-STENT PLACEMENT. THE TRANSDUCER CAUGHT ON THE STENT EDGE AND BROKE OFF IN THE VESSEL. THE DEVICE FRAGMENT WAS TRAPPED USING ANOTHER STENT. THE PROCEDURE WAS COMPLETED USING AN ALTERNATIVE METHOD, AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 22056626 ↗