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

Model Number	24674
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was non-tortuous and non-calcified vessel.An 8.0 x 80, 75cm mustang balloon catheter was advanced for dilatation.However, on initial inflation at 16 atmospheres, the balloon ruptured.The device was completely removed and the procedure was completed with another of same device.No patient complications were reported and the patient was stable.
Additional Manufacturer Narrative
A2.Age at time of event: 18 years or older.Device evaluated by mfr: mustang 8.0 x 80, 75cm, 20 atmospheres was received for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.A complete balloon circumferential tear was identified located approximately 5mm distal of the proximal balloon sleeve.The distal section of balloon material was also torn longitudinally beginning at the circumferential tear and extending for approximately 30mm distally.No other issues were noted with the balloon material during analysis.A visual and microscopic examination observed no damage to the tip of the device.A visual and tactile examination found the shaft of the device to be completely detached at two locations.The first location was at approximately 5mm distal of the proximal balloon sleeve and the second at the distal balloon bond.The detached section of shaft together with both markerbands was not returned for analysis.No other issues were noted with shaft.Both markerbands together with the detached section of shaft were not returned for analysis.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in a non-tortuous and non-calcified vessel.An 8.0 x 80, 75cm mustang balloon catheter was advanced for dilatation.However, on initial inflation at 16 atmospheres, the balloon ruptured.The device was completely removed and the procedure was completed with another of same device.No patient complications were reported and the patient was stable.

• 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: 12125627
• Report Number: 2134265-2021-08573
• Device Sequence Number: 11953135
• Product Code: FGE
• UDI-Device Identifier: 08714729793656
• UDI-Public: 08714729793656
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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): 07/30/2021

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: 09/28/2023
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0026093372
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2021
• Initial Date Received by Manufacturer: 06/18/2021
• Supplement Date Received by Manufacturer: 07/14/2021
• Initial Report FDA Received Date: 07/06/2021
• Supplement Report FDA Received Date: 07/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1