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

Model Number	H749CBM3200100
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in the coronary artery.A 10mm x 2mm flextome® cutting balloon® was selected for use.During the procedure, it was noted that the balloon failed to cross the target lesion.When balloon was removed, it became snagged on the tip of the guide catheter and the shaft became separated.The whole system was removed by pulling out.The procedure was completed with a different device.No patient complications were reported and patient's status was fine.
Additional Manufacturer Narrative
Device evaluated by mfr., eval summary attached, method codes, result codes, conclusion codes updated.Device evaluated by manufacturer: the device was returned for analysis.The device was received in two separate pieces for analysis consisting of the manifold with 75mm of hypotube and the balloon with the polymer extrusion, mid-shaft and 975mm of hypotube.A visual and tactile examination identified a complete break in the hypotube of the device.This type of damage is consistent with excessive tensile force being applied to the delivery system.No issues were noted with the hypotube that may have contributed to the complaint incident.The balloon folds were observed to be relaxed which may have occurred when the balloon protector was removed.There was no evidence that the balloon had been subjected to positive pressure.No issues were identified with the balloon that may have contributed to the compliant incident.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.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 caused by other device as another device/drug/subsequent procedure caused the complaint event.(b)(4).
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in the coronary artery.A 10mm x 2mm flextome® cutting balloon® was selected for use.During the procedure, it was noted that the balloon failed to cross the target lesion.When balloon was removed, it became snagged on the tip of the guide catheter and the shaft became separated.The whole system was removed by pulling out.The procedure was completed with a different device.No patient complications were reported and patient's status was fine.

• Brand Name: FLEXTOME® CUTTING BALLOON®
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7234324
• Report Number: 2134265-2018-00426
• Device Sequence Number: 1826967
• Product Code: NWX
• UDI-Device Identifier: 08714729808312
• UDI-Public: 08714729808312
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2018

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: 07/28/2019
• Device Model Number: H749CBM3200100
• Device Catalogue Number: CBM320010
• Device Lot Number: 0019528603
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2018
• Initial Date Received by Manufacturer: 01/11/2018
• Supplement Date Received by Manufacturer: 02/16/2018
• Initial Report FDA Received Date: 02/01/2018
• Supplement Report FDA Received Date: 03/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1