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

Model Number	24674
Medical Device Problem Codes	Leak/Splash (1354); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 09oct2024.It was reported that the amplatz wire could not cross the balloon.During the procedure, the device was flushed, and the amplatz was unable to cross.After making some adjustments, the balloon was able to cross.When the pressure reached standard pressure, the first inflation at 10 atmospheres for 1 minute revealed a leakage from the tip of the balloon.The device was removed, and the procedure was completed with another of the same device.The patient's status after the operation was stable.However, device analysis revealed to balloon pinhole.
Additional Manufacturer Narrative
Device evaluated by mfr: the mustang was returned for analysis.The mustang was returned for analysis, and investigation was completed on 09oct2024.The recommended guidewire size for this device is 0.035".The guidewire used by the customer was not returned for analysis.The investigator successfully loaded the device on to a boston scientific 0.035" guidewire without issue.A visual examination found that the balloon was not folded indicating that it was subjected to positive pressure.A balloon pinhole was identified located approximately 30mm proximal of the distal markerband.The rated burst pressure for this device is 24 atmospheres.A visual and tactile examination was performed on the balloon material, tip, shaft, and markerband of the device.There were no issues, kinks, or damages noted on the product analysis.Both markerbands were undamaged in the correct position on the device.

• 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: 20560245
• Report Number: 2124215-2024-67541
• Device Sequence Number: 8885966
• Product Code: FGE
• UDI-Device Identifier: 08714729793939
• UDI-Public: 08714729793939
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Report Date (Section B): 10/29/2024

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: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0033207557
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2024
• Initial Report FDA Received Date: 10/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/15/2024
• 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: Male