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	09/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr.: a mustang 6.0 x 120, 135cm was returned for analysis.A visual examination identified that the balloon was subjected to positive pressure.The returned device was attached to a boston scientific encore inflation unit.Positive pressure was applied using glycerol/water and a pinhole leak was identified 4mm distal from the proximal markerband.A visual examination found no issue with the tip section of the device.A visual examination found no issue with the markerbands.A visual and tactile examination identified no kinks or damage to the shaft of the device.
Event or Problem Description
Reportable based on device analysis completed on 28-jan-2022.It was reported that balloon leak occurred.A 6.0 x 120, 135cm mustang balloon catheter was advanced for dilatation.However, during the procedure balloon would not inflate.After withdrawal it was found that there was a leakage of serum and contrast.The procedure was completed with another of the same device.No patient complications were reported.However, returned device analysis revealed a balloon pinhole.

• Brand Name: MUSTANG
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13573304
• Report Number: 2134265-2022-01877
• Device Sequence Number: 5731432
• Product Code: FGE
• UDI-Device Identifier: 08714729793526
• UDI-Public: 08714729793526
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/21/2022

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: 11/10/2023
• Device Model Number: 24672
• Device Catalogue Number: 24672
• Device Lot Number: 0026331975
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/28/2022
• Initial Report FDA Received Date: 02/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/10/2020
• 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: 75 YR
• Patient Sex: Male