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	04/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 80% stenosed target lesion was located in the non-tortuous superficial femoral artery of the right lower limb.A 4.0 x 150, 135cm mustang balloon catheter was advanced for dilation.During the procedure, the balloon ruptured when it was primed to 12 atmospheres.The device was removed and replaced for another of the same model to complete the procedure.There were no complications reported, and patient status is fine.
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was returned for analysis.The balloon, markerband, shaft, and tip underwent a visual and tactile examination.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 specification.The returned device was attached to an encore inflation unit.Positive pressure was applied when deionized water was observed to be leaking from a balloon pinhole located approximately 20mm proximal from the distal markerband.No issues were found on the markerband, no kinks or damage to the shaft and tip.
Event or Problem Description
It was reported that balloon rupture occurred.The 80% stenosed target lesion was located in the non-tortuous superficial femoral artery of the right lower limb.A 4.0 x 150, 135cm mustang balloon catheter was advanced for dilation.During the procedure, the balloon ruptured when it was primed to 12 atmospheres.The device was removed and replaced for another of the same model to complete the procedure.There were no complications reported, and patient status is fine.It was further reported that the target lesion was 80%% stenosed and was non-tortuous and moderately calcified.The balloon ruptured on the first inflation when it was inflated for about 5 seconds.The device was simply removed.

• 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: 19247062
• Report Number: 2124215-2024-26924
• Device Sequence Number: 12411832
• Product Code: LIT
• UDI-Device Identifier: 08714729793694
• UDI-Public: 08714729793694
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2024

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: 04/27/2025
• Device Model Number: 24672
• Device Catalogue Number: 24672
• Device Lot Number: 0029303033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/16/2024
• Supplement Date Received by Manufacturer: 05/09/2024
• Initial Report FDA Received Date: 05/06/2024
• Supplement Report FDA Received Date: 05/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/2022
• 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: 81 YR
• Patient Sex: Male