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

Model Number	24674
Medical Device Problem Codes	Leak/Splash (1354); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.Initial reporter address 1: (b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.The 75% stenosed, about 10cm target lesion was located in a shunt in the moderately tortuous and non-calcified vein in the left forearm.After a 5f non-boston scientific (bsc) guide catheter and a.035 non-bsc guidewire were crossed the lesion, a 6.0 x 20, 40cm mustang balloon catheter was advanced for dilation.However, on the second inflation at 14 atmospheres for 30 seconds, the balloon ruptured.The device was removed and contrast agent was found to be leaking.The procedure was completed without replacing the device as the minimum necessary inflation was obtained.No patient complications were reported and the patient status was good.
Event or Problem Description
It was reported that balloon rupture occurred.The 75% stenosed, about 10cm target lesion was located in a shunt in the moderately tortuous and non-calcified vein in the left forearm.After a 5f non-boston scientific (bsc) guide catheter and a.035 non-bsc guidewire were crossed the lesion, a 6.0 x 20, 40cm mustang balloon catheter was advanced for dilation.However, on the second inflation at 14 atmospheres for 30 seconds, the balloon ruptured.The device was removed and contrast agent was found to be leaking.The procedure was completed without replacing the device as the minimum necessary inflation was obtained.No patient complications were reported and the patient status was good.
Additional Manufacturer Narrative
A2 - age at time of event: 18 years or older.E1- initial reporter address 1: (b)(6).Device evaluated by mfr.: a mustang 6mm x 2cm, 24atm, 40cm, was returned for analysis.A visual examination of the returned device found that the balloon had been inflated and was not refolded.It is not known when the balloon was subjected to positive pressure.No issues were noted with the balloon material which may have potentially contributed to the complaint incident.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 a shaft leak 10mm proximal of the proximal markerband.A visual and tactile examination of the tip identified no damage.No other issues were identified during the product 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: 12028640
• Report Number: 2134265-2021-07877
• Device Sequence Number: 16487785
• Product Code: FGE
• UDI-Device Identifier: 08714729793908
• UDI-Public: 08714729793908
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 07/19/2021

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: 10/07/2023
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0026141295
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2021
• Initial Date Received by Manufacturer: 06/04/2021
• Supplement Date Received by Manufacturer: 07/02/2021
• Initial Report FDA Received Date: 06/18/2021
• Supplement Report FDA Received Date: 07/19/2021
• 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: GUIDEWIRE USED: RADIFOCUS/035; GUIDEWIRE USED: RADIFOCUS/035; INTRODUCER SHEATH USED: RADIFOCUS/5FR; INTRODUCER SHEATH USED: RADIFOCUS/5FR