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

Model Number 24674

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/18/2022

Event Type  malfunction  

Event Description

It was reported that the balloon was leaking liquid.The stenosed target lesion was located in the percutaneous artery.After an unknown hydrophilic guidewire crossed the lesion, a 6.0 x 40, 135cm mustang balloon catheter was advanced for dilatation.However, during inflation at 22 atmospheres, the device was leaking liquid.The device was removed and tested, it was found that the device was indeed leaking liquid.The procedure was completed with another of the same device.There were no complications reported and the patient status was stable.

Manufacturer Narrative

Device evaluated by mfr: mustang 6.0 x 40, 135cm was received for analysis.A visual examination identified that the balloon was not folded, and inflation media was present inside it which indicates that the balloon was subjected to positive pressure.The returned device was attached to an encore inflation unit and positive pressure was applied, the balloon was inflated to its rate of burst pressure for 30 seconds without issue.A vacuum was then applied.This inflation to rate of burst pressure was repeated three times with no leaks or drop in pressure noted.No issues were identified with balloon inflation or the balloon material.No issues were noted with the tip section of the device.A visual examination found no issue with the markerbands.A visual and tactile examination found that the shaft was free from kinks or damage.

Event Description

It was reported that the balloon was leaking liquid.The stenosed target lesion was located in the percutaneous artery.After an unknown hydrophilic guidewire crossed the lesion, a 6.0 x 40, 135cm mustang balloon catheter was advanced for dilatation.However, during inflation at 22 atmospheres, the device was leaking liquid.The device was removed and tested, it was found that the device was indeed leaking liquid.The procedure was completed with another of the same device.There were no complications reported and the patient status was stable.It was further reported that the target lesion was more than 95% stenosed.

• Brand Name: MUSTANG
• Type of Device: 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: 14115921
• MDR Text Key: 289314846
• Report Number: 2134265-2022-03736
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 08714729793472
• UDI-Public: 08714729793472
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K141521
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/20/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 03/29/2024
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0027063637
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/21/2022
• Initial Date FDA Received: 04/14/2022
• Supplement Dates Manufacturer Received: 06/27/2022
• Supplement Dates FDA Received: 07/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Sex: Male