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

Model Number	24672
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the femoral artery.A 5.0 x 150, 135cm mustang balloon catheter was advanced for dilatation.During the procedure, the balloon ruptured upon inflation at 12 atmospheres for about 5 seconds.The device was removed along with the guidewire, and the procedure was completed with another of the same device.There was no patient complications reported, and the patient was stable after the procedure.
Additional Manufacturer Narrative
E1 - initial reporter facility name: (b)(6).
Additional Manufacturer Narrative
E1 - initial reporter facility name: (b)(6).Device evaluated by mfr: the device was returned for analysis.Visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.The rated burst pressure for this device is 24 atmospheres as per mustang.The returned device was attached to an encore inflation unit.Positive pressure was applied when di water was observed to be leaking from the distal tip.The catheter is compatible with a 0.035in (0.89 mm) guidewire.The investigator was unable to advance the guidewire through the device as it seemed to be restricted at 660mm proximal from the distal tip.The investigator was unable to flush the device.The device was soaked in the water bath at a temperature of 37 degrees celsius to investigate, as it may have been media that was restricting the guidewire from advancing through the device.When the device was removed from the water bath, the investigator was still unable to advance the guidewire through the device, which could potentially, be where the inner is damaged and resulting in the di water exiting the tip.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the femoral artery.A 5.0 x 150, 135cm mustang balloon catheter was advanced for dilatation.During the procedure, the balloon ruptured upon inflation at 12 atmospheres for about 5 seconds.The device was removed along with the guidewire, and the procedure was completed with another of the same device.There was no patient complications reported, and the patient was stable after the procedure.

• 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: 20200097
• Report Number: 2124215-2024-56856
• Device Sequence Number: 15121860
• Product Code: LIT
• UDI-Device Identifier: 08714729793434
• UDI-Public: 08714729793434
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 10/30/2024

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 Expiration Date: 05/15/2026
• Device Model Number: 24672
• Device Catalogue Number: 24672
• Device Lot Number: 0031617249
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2024
• Supplement Date Received by Manufacturer: 10/14/2024
• Initial Report FDA Received Date: 09/12/2024
• Supplement Report FDA Received Date: 10/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/16/2023
• 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: 53 YR
• Patient Sex: Male