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

Model Number	H74939171051510
Medical Device Problem Codes	Leak/Splash (1354); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D2b: product code: lit.G4: pma/510(k) # field on 3500a form: k110122, k141521.
Event or Problem Description
It was reported that balloon rupture occurred.The stenosed target lesion was located in the radial artery.A 5.0 x 150, 135cm mustang balloon catheter was advanced for dilatation.During the procedure, when the device was unpacked to reach the lesion site and it was found that the contrast medium overflowed and the pressure was unstable.After withdrawal, it was found that the balloon had a small breach.The device was removed successfully and the procedure was completed with another of the same device.There were no complications reported.
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.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 di water was observed to be leaking from a balloon pinhole located approximately 14mm proximal from the distal markerband.A visual examination of the device identified no issues with the markerbands, no kinks or damage to the shaft, and no damage to the tip.D2b: product code: lit.G4: pma/510(k) # field on 3500a form: k110122, k141521.
Event or Problem Description
It was reported that balloon rupture occurred.The stenosed target lesion was located in the radial artery.A 5.0 x 150, 135cm mustang balloon catheetr was advanced for dilatation.During the procedure, when the device was unpacked to reach the lesion site and it was found that the contrast medium overflowed and the pressure was unstable.After withdrawal, it was found that the balloon had a small breach.The device was removed successfully and the procedure was completed with another of the same device.There were no complications reported.

• 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: 20814928
• Report Number: 2124215-2024-75646
• Device Sequence Number: 9807120
• Product Code: FGE
• 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): 12/12/2024

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: H74939171051510
• Device Catalogue Number: H74939171051510
• Device Lot Number: 0033131124
• 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: 11/14/2024
• Supplement Date Received by Manufacturer: 12/05/2024
• Initial Report FDA Received Date: 12/01/2024
• Supplement Report FDA Received Date: 12/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/03/2024
• 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: 63 YR
• Patient Sex: Male
• Patient Weight: 60 KG