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

Model Number	24672
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon leak occurred.A 3.0 x 120, 135cm mustang balloon catheter was advanced for dilation.During the procedure, upon first inflation the balloon was found leaking.The device was tested outside the body.It was confirmed that the leak was within balloon material.The procedure was completed with a different device.No complications were reported, and the patient was stable.
Additional Manufacturer Narrative
E1: initial reported address 1:(b)(6).
Event or Problem Description
It was reported that balloon leak occurred.A 3.0 x 120, 135cm mustang balloon catheter was advanced for dilation.During the procedure, upon first inflation the balloon was found leaking.The device was tested outside the body.It was confirmed that the leak was within balloon material.The procedure was completed with a different device.No complications were reported, and the patient was stable.
Additional Manufacturer Narrative
E1: initial reported address 1: (b)(6).Device evaluated by mfr: the mustang was returned 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.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 45mm proximal from the distal 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.

• 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: 18987722
• Report Number: 2124215-2024-18313
• Device Sequence Number: 8265055
• Product Code: FGE
• UDI-Device Identifier: 08714729793816
• UDI-Public: 08714729793816
• Combination Product (Y/N): N
• Initial Reporter Country: ID
• 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): 09/05/2024

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 Expiration Date: 06/15/2026
• Device Model Number: 24672
• Device Catalogue Number: 24672
• Device Lot Number: 0031832181
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/05/2024
• Supplement Date Received by Manufacturer: 08/08/2024
• Initial Report FDA Received Date: 03/27/2024
• Supplement Report FDA Received Date: 09/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/16/2023
• 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