MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MUSTANG; CATHETER, BILIARY, DIAGNOSTIC

Model Number	24674
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: mustang was received for analysis.A visual examination identified that the balloon was not folded which indicates that the device was subjected to positive pressure.The returned device was attached to an encore inflation unit.Positive pressure was applied when liquid was observed to be leaking from a balloon pinhole located approximately 18mm proximal of the distal markerband.An examination of the balloon material and markerbands identified no issues which could potentially have contributed to this complaint.The rated burst pressure for this device is 14 atmospheres.A visual and microscopic examination observed no damage to the tip of the device.A visual and tactile examination found no kinks or damage to the shaft of the device.Both markerbands were undamaged and present on the shaft of the device.No other issues were identified during analysis.
Event or Problem Description
Reportable based on device analysis completed on 16-mar-2021.It was reported that balloon leak occurred.The 95% stenosed target lesion was located in the left iliac vein.After inserting a 6f introducer sheath and a 0.035 guidewire, thrombosis aspiration was performed with a angiojet thrombectomy system.The introducer sheath was replaced with a 9f sheath and a 8.0 x 80 mustang balloon catheter used to pre-dilate the lesion.A 10 x 80 self-expanding stent was implanted followed by a 12 x 90 wallstent venous stent.Subsequently, a 10.0 x 80, 135cm mustang balloon catheter was advanced for post-dilatation.However, during inflation at 4 atmospheres, contrast agent leakage was found.The device was removed from the patient's body and the procedure was completed with another of same device.There were no patient complications reported and the patient's status was stable.However, returned device analysis revealed balloon pinhole.

• Brand Name: MUSTANG
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11633804
• Report Number: 2134265-2021-03661
• Device Sequence Number: 11649270
• Product Code: FGE
• UDI-Device Identifier: 08714729795254
• UDI-Public: 08714729795254
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K141521
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/19/2023
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0025617633
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/16/2021
• Initial Report FDA Received Date: 04/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BALLOON CATHETER: 8X80 MUSTANG; STENT: 12X90 WALLSTENT; THROMBECTOMY SYSTEM: ANGIOJET
• Patient Age: 63 YR
• Patient Weight: 68