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

Model Number	24674
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/31/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon pinhole occurred.The target lesion was located in the central vein.After placing a 10fr sheath and a 0.035" guide wire, pre-dilatation was done with a 5x40mm balloon.A 10.0 x 60, 135cm mustang balloon catheter was advanced for further dilatation.However, during inflation, a leak of the contrast media was noticed.The device was removed and a pinhole was noted on the proximal part of the balloon.The procedure was completed with a different device.No patient complications were reported and the patient was stable.
Event or Problem Description
It was reported that balloon pinhole occurred.The target lesion was located in the central vein.After placing a 10fr sheath and a 0.035" guide wire, pre-dilatation was done with a 5x40mm balloon.A 10.0 x 60, 135cm mustang balloon catheter was advanced for further dilatation.However, during inflation, a leak of the contrast media was noticed.The device was removed and a pinhole was noted on the proximal part of the balloon.The procedure was completed with a different device.No patient complications were reported and the patient was stable.
Additional Manufacturer Narrative
Device evaluated by mfr.: mustang device 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 12mm proximal of the proximal markerband.An examination of the balloon material and markerbands identified no issues which could potentially have contributed to this complaint.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.

• 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: 11177397
• Report Number: 2134265-2021-00335
• Device Sequence Number: 14052817
• Product Code: FGE
• UDI-Device Identifier: 08714729795230
• UDI-Public: 08714729795230
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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,Followup
• Report Date (Section B): 03/03/2021

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: 07/08/2023
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0025683212
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2021
• Initial Date Received by Manufacturer: 12/31/2020
• Supplement Date Received by Manufacturer: 02/11/2021
• Initial Report FDA Received Date: 01/15/2021
• Supplement Report FDA Received Date: 03/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 34 YR
• Patient Weight: 55