MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MUSTANG; STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS

Model Number	H74939171070440
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D2b: product code - lit.G4: pma/510(k) # field on 3500a form - k141597.
Event or Problem Description
It was reported that balloon rupture occurred.The 75% stenosed target lesion was located in the shunt section vessel.A 7.0 x 40, 40cm mustang balloon cathetr was advanced for dilatation.During the procedure, the balloon ruptured after the first inflation at 16 atmospheres for few seconds.The device was removed without any problem, and the procedure was completed with another of the same device.There were no patient complications reported, and the patient was in good condition after the procedure.
Event or Problem Description
It was reported that balloon rupture occurred.The 75% stenosed target lesion was located in the shunt section vessel.A 7.0 x 40, 40cm mustang balloon cathetr was advanced for dilatation.During the procedure, the balloon ruptured after the first inflation at 16 atmospheres for few seconds.The device was removed without any problem, and the procedure was completed with another of the same device.There were no patient complications reported, and the patient was in good condition after the procedure.
Additional Manufacturer Narrative
Device evaluated by mfr: upon receipt at our post market quality assurance laboratory, visual inspection of the device revealed the balloon was not folded which indicates that the balloon was subjected to positive pressure.A leak test identified a balloon pinhole located approximately 4mm proximal of the proximal markerband.The rated burst pressure for this device is 20 atmospheres.A visual and tactile examination found no kinks or damage to the shaft, no damage to the tip, and observed no issues with the markerbands of the device.Both markerbands were undamaged in the correct position on the device.D2b: product code - lit.G4: pma/510(k) # field on 3500a form - k141597.

• Brand Name: MUSTANG
• Common Device Name: STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS
• 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: 21063361
• Report Number: 2124215-2024-82897
• Device Sequence Number: 8316673
• Product Code: FGE
• UDI-Device Identifier: 08714729793588
• UDI-Public: 08714729793588
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2025

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: H74939171070440
• Device Catalogue Number: H74939171070440
• Device Lot Number: 0034626127
• 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: 12/13/2024
• Supplement Date Received by Manufacturer: 01/21/2025
• Initial Report FDA Received Date: 01/02/2025
• Supplement Report FDA Received Date: 02/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/13/2024
• 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