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

Model Number 24674

Device Problems Inflation Problem (1310); Leak/Splash (1354); Material Puncture/Hole (1504)

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

Event Date 07/24/2021

Event Type  malfunction  

Event Description

It was reported that shaft hole occurred.The 75% stenosed target lesion was located in a shunt in the moderately tortuous radial cutaneous vein.A 4.0 x 40, 40 cm mustang balloon catheter was advanced for dilatation.However, during several inflations, the pressure did not increase.It went up once but the scale goes down when the handle was stopped.Subsequently, a hole in the shaft was noticed and leaked out but there was no rupture of the balloon observed.The procedure was completed using with this device.There were no patient complications nor injuries reported.

Manufacturer Narrative

Device evaluated by mfr: mustang 4.0 x 40, 40cm, batch# 56580110, 24atm was received for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.A visual and microscopic examination of the balloon material identified no issues which could potentially have contributed to this complaint.The returned device was attached to a boston scientific encore inflation unit.Positive pressure was applied but the balloon could not be fully inflated due to a shaft leak.The markerbands and tip of the device were visually and microscopically examined, and no issues were noted with the device that may have potentially contributed to the complaint incident.The returned device was attached to a boston scientific encore inflation unit.Positive pressure was applied, and liquid was observed to be exiting from a shaft pinhole located approximately 7mm proximal of the proximal markerband.No other damage or issues were noted with the shaft of the device.

Event Description

It was reported that shaft hole occurred.The 75% stenosed target lesion was located in a shunt in the moderately tortuous radial cutaneous vein.A 4.0 x 40, 40cm mustang balloon catheter was advanced for dilatation.However, during several inflations, the pressure did not increase.It went up once but the scale goes down when the handle was stopped.Subsequently, a hole in the shaft was noticed and leaked out but there was no rupture of the balloon observed.The procedure was completed using with this device.There were no patient complications nor injuries reported.

• Brand Name: MUSTANG
• Type of Device: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 12336103
• MDR Text Key: 267050342
• Report Number: 2134265-2021-09927
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 08714729794103
• UDI-Public: 08714729794103
• Combination Product (y/n): N
• PMA/PMN Number: K103751
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 09/15/2021

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: 01/05/2024
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0026580110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2021
• Initial Date Manufacturer Received: 07/26/2021
• Initial Date FDA Received: 08/18/2021
• Supplement Dates Manufacturer Received: 08/27/2021
• Supplement Dates FDA Received: 09/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1