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

Model Number	24673
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon burst occurred.The target lesion was located in an arteriovenous fistula.A 7.0 x 200, 75cm mustang balloon catheter was advanced for dilation.During the procedure, it was noted that the balloon burst on nominal burst pressure.The procedure was completed with another of the same device.No complications were reported, and the patient was stable.
Additional Manufacturer Narrative
Correction of d4 lot number from 0033265309 to 0033035221.Correction of d4 expiration date from 01/22/2027 to 12/11/2026.Correction of h6: evaluation conclusion codes from adverse event related to procedure, d1002 to adverse event related to patient condition, d1001.
Event or Problem Description
It was reported that balloon burst occurred.The target lesion was located in an arteriovenous fistula.A 7.0 x 200, 75cm mustang balloon catheter was advanced for dilation.During the procedure, it was noted that the balloon burst on nominal burst pressure.The procedure was completed with another of the same device.No complications were reported, and the patient was stable.It was further reported that the stenosis was 70-80%, with a mildly tortuous and non-calcified arteriovenous fistula lesion.

• 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; pmt 741 persiaran cassia selat; bandarcassia, pulau pinan 14110 ; MY 14110
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19387842
• Report Number: 2124215-2024-31454
• Device Sequence Number: 14461993
• Product Code: LIT
• UDI-Device Identifier: 08714729794189
• UDI-Public: 08714729794189
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2024

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 Model Number: 24673
• Device Catalogue Number: 24673
• Device Lot Number: 0033035221
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2024
• Supplement Date Received by Manufacturer: 07/11/2024
• Initial Report FDA Received Date: 05/23/2024
• Supplement Report FDA Received Date: 08/07/2024
• Date Device Manufactured: 12/12/2023
• 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 Age: 71 YR
• Patient Sex: Male