MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY GLADIATOR¿; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number H74939207060440

Device Problem Hole In Material (1293)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/08/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that balloon hole/leak occurred.The target lesion was located in the arteriovenous fistula.A 6.0 x40 40cm gladiator balloon catheter was advanced for dilation however, it was noted that the balloon had a hole/leak in the neck.The procedure was completed with a different device.No patient complications were reported and the patient's status was stable.

Manufacturer Narrative

Event date, describe event or problem, device evaluated by mfr., eval summary attached, method codes, result codes, conclusion codes updated.Device evaluated by mfr.: the device was received for analysis.No kinks or damage were visible along the entire length of the device.An examination of the balloon found that the balloon exhibited clear signs of having been inflated and deflated.No tears or holes were present in the balloon material.As part of the functional testing the device was attached to an encore inflation unit and the balloon was attempted to be inflated to its rated burst pressure; however, a drop in pressure was identified when the device reached 12 atmospheres.The droplet leak was visible under the strain relief.The strain relief was removed and leak was found to be coming out from where the shaft enters to moulded hub.Using the same encore inflation unit, liquid was inflated through the wire port in the hub and the shaft was clamped distally along the shaft.No leak was confirmed coming back out the inflation port in the hub.This confirmed that there was no breach between the inflation and the wire lumen.The leak was concluded to be coming out from the hub/shaft connection.The origin of the leak could not be identified.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is manufacturing execution error as the manufacturing process was not executed as validated/as designed.  (b)(4).

Event Description

It was further reported that the hole/leak was noted during the first inflation.The device was completely removed from the patient's body.

• Brand Name: GLADIATOR¿
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• 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: 7316919
• MDR Text Key: 101726848
• Report Number: 2134265-2018-01439
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113681
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/21/2020
• Device Model Number: H74939207060440
• Device Catalogue Number: 3920706044
• Device Lot Number: 0021421642
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/06/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/22/2017
• 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