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

Model Number 24674

Device Problems Leak/Splash (1354); Material Rupture (1546)

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

Event Date 11/23/2021

Event Type  malfunction  

Event Description

It was reported that balloon rupture occurred.The patient was treated for deep vein thrombosis for stenotic lesion in the left lower extremity.A 12.0 x 80, 135cm mustang balloon catheter was selected for pre-dilation.However, after the balloon was introduced through the guide wire, the balloon was leaking liquid and pressure could not come up.The balloon was found to be damaged upon checking.The device was replaced with another 12mmx80mm mustang balloon catheter and the procedure was completed.There were no patient complications reported and the patient was stable.

Event Description

It was reported that balloon rupture occurred.The patient was treated for deep vein thrombosis for stenotic lesion in the left lower extremity.A 12.0 x 80, 135cm mustang balloon catheter was selected for pre-dilation.However, after the balloon was introduced through the guide wire, the balloon was leaking liquid and pressure could not come up.The balloon was found to be damaged upon checking.The device was replaced with another 12mmx80mm mustang balloon catheter and the procedure was completed.There were no patient complications reported and the patient was stable.It was further reported that the balloon was inflated once in less working pressure for a few seconds.

Event Description

It was reported that balloon rupture occurred.The patient was treated for deep vein thrombosis for stenotic lesion in the left lower extremity.A 12.0 x 80, 135cm mustang balloon catheter was selected for pre-dilation.However, after the balloon was introduced through the guide wire, the balloon was leaking liquid and pressure could not come up.The balloon was found to be damaged upon checking.The device was replaced with another 12mmx80mm mustang balloon catheter and the procedure was completed.There were no patient complications reported and the patient was stable.It was further reported that the balloon was inflated once in less working pressure for a few seconds.

Manufacturer Narrative

Device evaluated by mfr.: mustang 12.0 x 80, 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.A balloon longitudinal tear was identified beginning at the proximal balloon bond and extending distally across the balloon material to the distal balloon bond.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 to 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.

• 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12907926
• MDR Text Key: 281504167
• Report Number: 2134265-2021-15106
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 08714729795285
• UDI-Public: 08714729795285
• 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,Followup
• Report Date: 01/25/2022

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: 04/14/2024
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0027145618
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/23/2021
• Initial Date FDA Received: 12/01/2021
• Supplement Dates Manufacturer Received: 11/29/2021; 01/17/2022
• Supplement Dates FDA Received: 12/06/2021; 01/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/15/2021
• 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: 48 YR
• Patient Sex: Female
• Patient Weight: 50 KG