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

Model Number	H749CBM3300100
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that a catheter shaft break occurred.A 10/3.00 flextome cutting balloon was selected for use.During preparation, when they pulled the flextome balloon out of the hoop to press it, it was noted that there was a kink in the shaft about 4-6 inches from the hub.The device was not used into the patient's body.When the balloon was put back in the hoop, it was further noted that the shaft completely broke in two.The procedure was completed with another of the same device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.A visual and tactile examination identified a complete break in the hypotube of the device.A kink on the hypotube was also identified located approximately 60mm distal of the strain relief.This type of damage is consistent with excessive force being applied to the delivery system.A visual examination identified that the balloon was tightly folded indicating that the balloon had not been subjected to positive pressure.A visual and microscopic examination identified no damage to the tip, markerbands or blades of the device.All blades were present and fully bonded to the balloon material.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 or Problem Description
It was reported that a catheter shaft break occurred.A 10/3.00 flextome cutting balloon was selected for use.During preparation, when they pulled the flextome balloon out of the hoop to press it, it was noted that there was a kink in the shaft about 4-6 inches from the hub.The device was not used into the patient's body.When the balloon was put back in the hoop, it was further noted that the shaft completely broke in two.The procedure was completed with another of the same device.No patient complications were reported.

• Brand Name: FLEXTOME® CUTTING BALLOON®
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7289574
• Report Number: 2134265-2018-01235
• Device Sequence Number: 16176933
• Product Code: NWX
• UDI-Device Identifier: 08714729808350
• UDI-Public: 08714729808350
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P950020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/26/2020
• Device Model Number: H749CBM3300100
• Device Catalogue Number: CBM330010
• Device Lot Number: 21432434
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2018
• Initial Date Received by Manufacturer: 01/31/2018
• Supplement Date Received by Manufacturer: 03/05/2018
• Initial Report FDA Received Date: 02/22/2018
• Supplement Report FDA Received Date: 03/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1