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

Model Number	H749CBM3250100
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/06/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that a catheter shaft break occurred.Vascular access was obtained via the right femoral artery.The target lesion was located in the coronary artery.A 10/2.50 flextome® cutting balloon® was selected for use.During procedure, the catheter was advanced towards the target lesion when the device became kinked.The physician had to keep pushing the catheter inside the guide catheter, which eventually caused the shaft to break on the cutting balloon.The flextome was removed together with the wire as the broken component was still inside the guide catheter.The procedure was completed with a different device.No patient complications were reported and the patient's status was fine.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.A visual and tactile examination identified a break in the hypotube, 570mm distal to the strain relief.Multiple kinks were also noted along the hypotube of the device.This type of damage is consistent with excessive force being applied to the delivery system.No issues were noted with the hypotube that may have contributed to the complaint incident.A visual and tactile examination identified multiple kinks along the shaft polymer extrusion; this type of damage is consistent with excessive force being applied to the delivery system.No issues were noted with the shaft 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.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 most probable root cause has been determined to be use/user error as the dfu notes: ¿at any time during use of the flextome cutting balloon device, if the stainless steel proximal shaft has been bent or kinked, do not continue to use the catheter.¿ (b)(4).
Event or Problem Description
It was reported that a catheter shaft break occurred.Vascular access was obtained via the right femoral artery.The target lesion was located in the coronary artery.A 10/2.50 flextome® cutting balloon® was selected for use.During procedure, the catheter was advanced towards the target lesion when the device became kinked.The physician had to keep pushing the catheter inside the guide catheter, which eventually caused the shaft to break on the cutting balloon.The flextome was removed together with the wire as the broken component was still inside the guide catheter.The procedure was completed with a different device.No patient complications were reported and the 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: 6657665
• Report Number: 2134265-2017-06290
• Device Sequence Number: 13822568
• Product Code: NWX
• UDI-Device Identifier: 08714729808336
• UDI-Public: (01)08714729808336(17)20200412(10)0020523450
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 06/06/2017

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: 04/12/2020
• Device Model Number: H749CBM3250100
• Device Catalogue Number: CBM325010
• Device Lot Number: 0020523450
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2017
• Initial Date Received by Manufacturer: 06/06/2017
• Supplement Date Received by Manufacturer: 07/06/2017
• Initial Report FDA Received Date: 06/21/2017
• Supplement Report FDA Received Date: 07/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR