MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY FLEXTOME® CUTTING BALLOON®; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number H749CBM3400150

Device Problem Detachment Of Device Component (1104)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

It was reported that a balloon tip detachment occurred.A 15/4.00 flextome® cutting balloon® catheter was selected for use.During preparation, upon pulling out the stylet, the tip of the balloon came off.The procedure was completed with a different device.There were no patient complications reported and the patient's status was fine.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Device evaluated by manufacturer: device was returned for analysis.The balloon protector cap was returned over the balloon.The proximal blade sections were exposed which is indicative of the balloon protector being pulled distally.It was not possible to apply a vacuum to the balloon to remove all air prior to balloon protector removal as the midshaft was broken however during device evaluation, the balloon protector was able to be removed from the balloon with no force required.The returned balloon protector inner dimension was verified using a pin gauge and was found to be within specification.Upon removal of the protector cap, there was no damage noted to the tip, balloon, or blades.A visual examination of the catheter revealed that the midshaft was detached at the guidewire exit port and was stretched for a distance of 5 mm proximal to the break and 0.5 mm distal to the break.The outer and the hypotube were kinked at several locations along their length.This is evidence of excessive tensile force being applied to the device.Microscopic examination revealed that the blades and folds are correctly aligned within protector cap channels.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is considered handling damage as the event occurred without direct patient contact.(b)(4).

Event Description

It was reported that a balloon tip detachment occurred.A 15/4.00 flextome cutting balloon catheter was selected for use.During preparation, upon pulling out the stylet, the tip of the balloon came off.The procedure was completed with a different device.There were no patient complications reported and the patient's status was fine.

• Brand Name: FLEXTOME® CUTTING BALLOON®
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY; ballybrit business park; galway
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY; ballybrit business park; galway
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 4899374
• MDR Text Key: 6830715
• Report Number: 2134265-2015-04222
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P950020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/09/2018
• Device Model Number: H749CBM3400150
• Device Catalogue Number: CBM340015
• Device Lot Number: 17775054
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/03/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/27/2015
• 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