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

Model Number	24674
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.An 8.0 x 80, 135cm mustang balloon catheter was advanced for dilatation.However, during inflation before reaching the rated burst pressure, the balloon burst.The procedure was completed with another of the same device.There were no patient complications reported and the patient status was stable.
Additional Manufacturer Narrative
Device evaluated by mfr.: a mustang device 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 20 atmospheres as per mustang specification.The returned device was attached to an encore inflation unit.Positive pressure was applied when liquid was observed to be leaking from a balloon pinhole located approximately 24mm distal from the proximal markerband.A visual examination of the markerbands identified no issues which may potentially have contributed to the complaint incident.A visual and tactile examination identified no kinks or damage to the shaft which may have potentially contributed to the complaint incident.A visual and tactile examination identified no damage to the tip which may have potentially contributed to the complaint incident.
Event or Problem Description
It was reported that balloon rupture occurred.An 8.0 x 80, 135cm mustang balloon catheter was advanced for dilatation.However, during inflation before reaching the rated burst pressure, the balloon burst.The procedure was completed with another of the same device.There were no patient complications reported and the patient status was stable.It was further reported that the inflation was performed several times at less working pressure for few seconds.Furthermore, the device was completely removed from the patient's body.
Event or Problem Description
It was reported that balloon rupture occurred.An 8.0 x 80, 135cm mustang balloon catheter was advanced for dilatation.However, during inflation before reaching the rated burst pressure, the balloon burst.The procedure was completed with another of the same device.There were no patient complications reported and the patient status was stable.It was further reported that the inflation was performed several times at less working pressure for few seconds.Furthermore, the device was completely removed from the patient's body.

• 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: 13568603
• Report Number: 2134265-2022-01902
• Device Sequence Number: 4119121
• Product Code: FGE
• UDI-Device Identifier: 08714729794301
• UDI-Public: 08714729794301
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/28/2022

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: 04/18/2024
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0027161304
• 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: 02/10/2022
• Supplement Date Received by Manufacturer: 02/22/2022; 03/11/2022
• Initial Report FDA Received Date: 02/21/2022
• Supplement Report FDA Received Date: 02/25/2022; 03/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/19/2021
• 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: 46 YR
• Patient Sex: Male
• Patient Weight: 65 KG