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	07/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter address 1: (b)(6).Initial reporter city: (b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.The 99% stenosed target lesion was located in the moderately tortuous and severely calcified external iliac artery.A 7.0 x 20, 75cm mustang balloon catheter was advanced for dilation.However, on initial inflation at 18 atmospheres for 2 seconds, the balloon ruptured.The device was removed without any problem and the procedure was completed with a different device.There were no patient complications nor injury reported, and the patient was in good condition after the procedure.
Event or Problem Description
It was reported that balloon rupture occurred.The 99% stenosed target lesion was located in the moderately tortuous and severely calcified external iliac artery.A 7.0 x 20, 75cm mustang balloon catheter was advanced for dilation.However, on initial inflation at 18 atmospheres for 2 seconds, the balloon ruptured.The device was removed without any problem and the procedure was completed with a different device.There were no patient complications nor injury reported, and the patient was in good condition after the procedure.
Additional Manufacturer Narrative
E1.Initial reporter address 1: (b)(6).E1.Initial reporter city: (b)(6).Device evaluated by manufacterer : mustang 7.0 x 20, 75cm, batch# 24360504, 20atm was received for analysis.A visual examination identified that the balloon was not folded which indicates that the device was subjected to positive pressure.A microscopic examination identified a balloon longitudinal tear beginning approximately 1mm proximal of the proximal markerband and extending approximately 29mm distally across the balloon material.An examination of the balloon material and markerbands identified no issues which could potentially have contributed to this complaint.The rated burst pressure for this device is 20 atmospheres.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: 12222253
• Report Number: 2134265-2021-09516
• Device Sequence Number: 11693339
• Product Code: FGE
• UDI-Device Identifier: 08714729793502
• UDI-Public: 08714729793502
• 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): 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: 09/01/2022
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0024360504
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2021
• Initial Date Received by Manufacturer: 07/02/2021
• Supplement Date Received by Manufacturer: 08/10/2021
• Initial Report FDA Received Date: 07/23/2021
• 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