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	07/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The patient underwent percutaneous transluminal angioplasty (pta).The target lesion was located in the common iliac artery.After a.035 unspecified guidewire was inserted, an 8.0 x 60, 135cm mustang balloon catheter was advanced for dilation; however, the balloon ruptured.The procedure was completed with another of same device.No patient complications were reported.
Event or Problem Description
It was reported that balloon rupture occurred.The patient underwent percutaneous transluminal angioplasty (pta).The target lesion was located in the common iliac artery.After a.035 unspecified guidewire was inserted, an 8.0 x 60, 135cm mustang balloon catheter was advanced for dilation; however, the balloon ruptured.The procedure was completed with another of same device.No patient complications were reported.It was further reported that the stenosed target lesion was totally occluded located in the severely tortuous and severely calcified common iliac artery.
Additional Manufacturer Narrative
B5 - describe event or problem updated.

• Brand Name: MUSTANG
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17435857
• Report Number: 2124215-2023-40656
• Device Sequence Number: 15155600
• Product Code: FGE
• UDI-Device Identifier: 08714729794714
• UDI-Public: 08714729794714
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2023

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: 02/27/2023
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0025279815
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/27/2023
• Supplement Date Received by Manufacturer: 08/01/2023
• Initial Report FDA Received Date: 08/01/2023
• Supplement Report FDA Received Date: 08/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown