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	07/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the left forearm vessel.A 4.0 x 20, 40cm mustang balloon catheter was advanced for dilatation.However, the balloon ruptured during inflation.No patient complications were reported.
Additional Manufacturer Narrative
(e1) initial reporter city: (b)(6).Device evaluated by mfr.: mustang 4.0 x 20, 40cm 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 visual and microscopic examination of the balloon material identified no issues which could potentially have contributed to this complaint.The returned device was attached to a boston scientific encore inflation unit.Positive pressure was applied but the balloon could not be fully inflated due to a shaft leak.The markerbands and tip of the device were visually and microscopically examined, and no issues were noted with the device that may have potentially contributed to the complaint incident.The returned device was attached to a boston scientific encore inflation unit.Positive pressure was applied, and liquid was observed to be exiting from a shaft pinhole located approximately 1mm proximal of the proximal balloon sleeve.This type of damage may have occurred due to excessive force being applied when loading the device on to the guidewire or an interaction with a sharp object.No other damage or issues were noted with the shaft of the device.No other issues were identified during product analysis.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the left forearm vessel.A 4.0 x 20, 40cm mustang balloon catheter was advanced for dilatation.However, the balloon ruptured during inflation.No patient complications were reported.

• 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: 12171710
• Report Number: 2134265-2021-09047
• Device Sequence Number: 11602206
• Product Code: FGE
• UDI-Device Identifier: 08714729794172
• UDI-Public: 08714729794172
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K103751
• 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): 08/16/2021

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: 10/05/2023
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0026125503
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2021
• Initial Date Received by Manufacturer: 07/01/2021
• Supplement Date Received by Manufacturer: 08/10/2021
• Initial Report FDA Received Date: 07/15/2021
• Supplement Report FDA Received Date: 08/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1