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

Model Number	H74939171072070
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 11-nov 2024.It was reported that the balloon failed to inflate.The target lesion was located in a severely stenosed arteriovenous graft.A 7.0 x 200, 75cm mustang balloon catheter was advanced for dilatation.The balloon was inflated to 23 atmospheres but was not able to fully expand.The device was replaced with an athletis balloon catheter, and the procedure was completed.No patient complications were reported.However, returned device analysis revealed a balloon pinhole.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was received for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.A leak test identified a balloon pinhole located approximately 6mm distal of the proximal markerband.It is not possible to fully inflate the balloon due to the balloon pinhole.The rated burst pressure for this device as per specification is 18 atmospheres.A visual and tactile examination found no kinks or damage to the shaft, no damage to the tip, and no issues with the markerbands of the device.D2b - pro code (product code: lit.G4- pma/510(k) # field on 3500a form: k110122, k141521.

• 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: 20810984
• Report Number: 2124215-2024-75508
• Device Sequence Number: 21145785
• Product Code: FGE
• 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
• Report Date (Section B): 11/29/2024

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: H74939171072070
• Device Catalogue Number: H74939171072070
• Device Lot Number: 0033717381
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2024
• Initial Report FDA Received Date: 11/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/28/2024
• 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 Age: 88 YR
• Patient Sex: Male