MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY MUSTANG¿; CATHETER, BILIARY, DIAGNOSTIC

Model Number H74939171050610

Device Problem Hole In Material (1293)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/08/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that balloon pinhole occurred.The target lesion was located in the mildly calcified hepatic artery.A 5.0 x 60 135cm mustang¿ balloon catheter was advanced for dilation.However, when the balloon was initially inflated at 3 atmospheres with the used of 26 encore balloon catheter inflation device, the balloon was unable to be inflated; hence pinhole was noted.The device was completely removed from the patient and the procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.

Manufacturer Narrative

Device evaluated by mfr: the 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 returned device was attached to an encore inflation unit and positive pressure was applied using glycerol/water inflation media.Liquid was observed to be leaking from a balloon longitudinal tear beginning approximately 10mm distal to the distal end of the proximal markerband and extending approximately 10mm distally across the balloon material.An examination of the balloon material and markerbands identified no issues which could potentially have contributed to this complaint.A visual and microscopic examination found no issues with the markerbands that could have contributed to the complaint incident.Tip damage was noted.This type of damage is consistent with excess force being applied as a result of meeting resistance during the attempt to cross a lesion.A visual and tactile examination found no kinks or damage along the shaft of the device.No other issues were noted with the device during analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is operational context as the product meets the design and manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).

Event Description

It was reported that balloon pinhole occurred.The target lesion was located in the mildly calcified hepatic artery.A 5.0 x 60 135cm mustang balloon catheter was advanced for dilation.However, when the balloon was initially inflated at 3 atmospheres with the used of 26 encore balloon catheter inflation device, the balloon was unable to be inflated; hence pinhole was noted.The device was completely removed from the patient and the procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.

• Brand Name: MUSTANG¿
• Type of Device: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7488247
• MDR Text Key: 107402386
• Report Number: 2134265-2018-03965
• Device Sequence Number: 1
• Product Code: FGE
• Combination Product (y/n): N
• Reporter Country Code: CN
• PMA/PMN Number: K110122
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/13/2020
• Device Model Number: H74939171050610
• Device Catalogue Number: 39171-05061
• Device Lot Number: 0020525918
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/14/2017
• 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