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

Model Number	24674
Medical Device Problem Codes	Inflation Problem (1310); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.The severely stenosed target lesion was located in central vein.A 12.0 x 40, 135cm mustang balloon catheter was advanced for dilation.During initial inflation, at less working pressure for few seconds, the balloon failed to fully inflate, and burst during the process.The balloon did not detach inside the patient after it ruptured.The device was removed and the procedure was completed with another of same device.There were no patient complications reported.The patient was stable following the procedure.
Additional Manufacturer Narrative
E1: initial reporter facility name: (b)(6) hospital.Device evaluated by mfr.: mustang 12.0 x 40, 135cm was received for analysis.A visual examination identified that the balloon was not folded which indicates that the device was subjected to positive pressure.Blood was identified within the balloon which is evidence of a device leak.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 4mm distal of the proximal markerband.An examination of the balloon material and markerbands identified no issues which could potentially have contributed to this complaint.A visual examination observed no issues or damage to the tip of the device.A visual and tactile examination found no kinks or damage the shaft of the device.A visual examination observed no issues with the markerbands of the device.Both markerbands were undamaged and present on the shaft of the device.This concludes the product analysis.
Event or Problem Description
It was reported that balloon rupture occurred.The severely stenosed target lesion was located in central vein.A 12.0 x 40, 135cm mustang balloon catheter was advanced for dilation.During initial inflation, at less working pressure for few seconds, the balloon failed to fully inflate, and burst during the process.The balloon did not detach inside the patient after it ruptured.The device was removed and the procedure was completed with another of same device.There were no patient complications reported.The patient was stable following the procedure.

• 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15136083
• Report Number: 2124215-2022-25617
• Device Sequence Number: 14769439
• Product Code: FGE
• UDI-Device Identifier: 08714729793953
• UDI-Public: 08714729793953
• 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
• Report Date (Section B): 08/29/2022

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: 05/06/2024
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0027271552
• 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: 07/06/2022
• Supplement Date Received by Manufacturer: 08/26/2022
• Initial Report FDA Received Date: 07/29/2022
• Supplement Report FDA Received Date: 08/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/07/2021
• 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: 68 YR
• Patient Sex: Male
• Patient Weight: 80 KG