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	06/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter first name: (b)(6).
Event or Problem Description
It was reported that balloon had a pinhole.The 60% stenosed, target lesion was located in a non-tortuous and mildly calcicifed iliac vein.A 12.0 x 60, 135cm mustang balloon catheter was positioned where it was advanced for dilatation.However, during inflation at 8 atmospheres, a contrast medium leak was observed at the proximal end of the balloon.The device was simply pulled out from the patient's body and the leak was confirmed.The procedure was completed with a new 12.0x60x135cm mustang balloon.No patient complications were reported and the patient's status was fine.
Additional Manufacturer Narrative
E1 - initial reporter first name: (b)(6).Device evaluated by mfr: a mustang 12mm x 6cm, 14atm was returned for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.The rated burst pressure for this device is 14 atmospheres as per mustang specification.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 15mm proximal from the proximal markerband.A visual and microscopic examination of the markerbands identified no issues which may potentially have contributed to the complaint incident.A visual and tactile examination identified no kinks or damage to the shaft or tip which may have potentially contributed to the complaint incident.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that balloon had a pinhole.The 60% stenosed, target lesion was located in a non-tortuous and mildly calcified iliac vein.A 12.0 x 60, 135cm mustang balloon catheter was positioned where it was advanced for dilatation.However, during inflation at 8 atmospheres, a contrast medium leak was observed at the proximal end of the balloon.The device was simply pulled out from the patient's body and the leak was confirmed.The procedure was completed with a new 12.0x60x135cm mustang balloon.No patient complications were reported and the patient's status was fine.

• 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: 12143531
• Report Number: 2134265-2021-08562
• Device Sequence Number: 4170338
• Product Code: FGE
• UDI-Device Identifier: 08714729795018
• UDI-Public: 08714729795018
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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): 08/23/2021

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: 04/24/2023
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0025467571
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2021
• Initial Date Received by Manufacturer: 06/20/2021
• Supplement Date Received by Manufacturer: 08/04/2021
• Initial Report FDA Received Date: 07/09/2021
• Supplement Report FDA Received Date: 08/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 38 YR