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

Model Number H749CBO3400100

Device Problem Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/05/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was returned for evaluation.A visual and microscopic examination was performed and noted the balloon folds were relaxed which may have occurred during removal of the balloon protector or the balloon may have been subjected to positive pressure.Examination of the balloon material identified no issues that could have contributed to the issue.Examination of the blades noted that approximately 3mm of one of the blades was completely detached from the balloon material, leaving approximately 7mm of the blade still attached to the balloon material.This detached section of blade was not returned for analysis.The pad was intact and still fully attached to the balloon material, however it was noted that the proximal section of the pad was slightly lifted from the balloon material this may have occurred when the section of the blade detached.All other blades and pads were present and fully bonded to the balloon material.No issues were noted with the blades or pads that could have contributed to the complaint incident.A kink was also observed at 112mm proximal to the tip of the device on the shaft polymer extrusion, along with multiple smaller kinks along the length of the device.No damage or any issues were noted to the tip or markerbands of the device.No other issues were identified during the product analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is handling damage as the complaint was caused by handling of the device or portion of the device without direct patient contact.(b)(4).

Event Description

Reportable based on device analysis completed on 06-dec-2017.It was reported that the atheretomes were not the same length or depth.A 10/4.00 flextome® cutting balloon® was selected for percutaneous coronary intervention.During preparation, outside patient's body, it was noted that the atheretomes were not the same length/depth.The procedure was completed with another of the same device.There were no patient complications reported.However, device analysis revealed that one of the blades was completely detached from the balloon.

• Brand Name: FLEXTOME® CUTTING BALLOON®
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• 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: 7130228
• MDR Text Key: 95534701
• Report Number: 2134265-2017-12488
• Device Sequence Number: 1
• Product Code: NWX
• UDI-Device Identifier: 08714729808664
• UDI-Public: 08714729808664
• 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: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 12/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/13/2020
• Device Model Number: H749CBO3400100
• Device Catalogue Number: CBO340010
• Device Lot Number: 20280421
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/22/2017
• 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