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

Model Number	24674
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for evaluation.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 14 atmospheres as per mustang specification.The returned device was attached to an encore inflation unit.Positive pressure was applied when deionized (di) water was observed to be leaking from a balloon pinhole located approximately 13mm proximal from the proximal markerband.A visual examination of the markerbands identified no issues.A visual and tactile examination identified no kinks or damage to the shaft.A visual and tactile examination identified no damage to the tip.No other issues were identified with the device and no patient complications were reported.
Event or Problem Description
Reportable based on device analysis completed on 11nov2024.It was reported that balloon leak occurred.The stenosed target lesion was located in the subclavian vein.A 12.0 x 40, 75cm mustang balloon catheter was advanced for dilation.During inflation, the contrast agent leaked from the bottom of the radio maker.The procedure was completed with another of the same device.No complications were reported, and patient was normal post procedure.However, device analysis revealed a balloon pinhole.
Event or Problem Description
Reportable based on device analysis completed on 11nov2024.It was reported that balloon leak occurred.The stenosed target lesion was located in the subclavian vein.A 12.0 x 40, 75cm mustang balloon catheter was advanced for dilation.During inflation, the contrast agent leaked from the bottom of the radio maker.The procedure was completed with another of the same device.No complications were reported, and patient was normal post procedure.However, device analysis revealed a balloon pinhole.It was further noted that the target lesion exhibited 70% stenosis.The procedure involved a single inflation at nominal pressure, with the duration of inflation limited to one instance.
Additional Manufacturer Narrative
The device was returned for evaluation.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 14 atmospheres as per mustang specification.The returned device was attached to an encore inflation unit.Positive pressure was applied when deionized (di) water was observed to be leaking from a balloon pinhole located approximately 13mm proximal from the proximal markerband.A visual examination of the markerbands identified no issues.A visual and tactile examination identified no kinks or damage to the shaft.A visual and tactile examination identified no damage to the tip.No other issues were identified with the device and no patient complications were reported.

• 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: 20768071
• Report Number: 2124215-2024-74068
• Device Sequence Number: 9292205
• Product Code: FGE
• UDI-Device Identifier: 08714729793441
• UDI-Public: 08714729793441
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 12/11/2024

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: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0034626397
• 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
• Supplement Date Received by Manufacturer: 11/21/2024
• Initial Report FDA Received Date: 11/24/2024
• Supplement Report FDA Received Date: 12/11/2024
• 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 Age: 55 YR
• Patient Sex: Male