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

Model Number	H749CBM3400150
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/10/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: approximately (b)(6).(b)(4).The device was returned for analysis.A visual and microscopic examination of the balloon material identified no issues that could have contributed to the complaint incident.A visual and microscopic examination markerbands, blades and tip identified no damage.All blades were present and fully bonded to the balloon material.A visual and tactile examination of hypotube identified multiple kinks along the hypotube of the device.This type of damage is consistent with excessive force being applied to the delivery system during device use.A visual and tactile examination of the shaft identified a break in the mid shaft of the device 1245mm distal to the strain relief.The device was received in two separate pieces for analysis.This type of damage is consistent with excessive force being applied to the delivery system during device use.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 is considered handling damage as the event occurred without direct patient contact.(b)(4).
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in the right common femoral artery.A 15mm x4mm flextome® cutting balloon® was selected for use.During preparation, when device was opened and as it was taken out of the hoop, it was noted that the shaft of the catheter came apart outside the patient's body.The procedure was completed with a 10mm x 4mm flextome® cutting balloon®.No patient complications reported.

• Brand Name: FLEXTOME® CUTTING BALLOON®
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 6601009
• Report Number: 2134265-2017-05238
• Device Sequence Number: 19119706
• Product Code: NWX
• UDI-Device Identifier: 08714729808480
• UDI-Public: (01)08714729808480(17)20191111(10)19954454.
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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
• Report Date (Section B): 05/10/2017

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: 11/11/2019
• Device Model Number: H749CBM3400150
• Device Catalogue Number: CBM340015
• Device Lot Number: 19954454
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2017
• Initial Report FDA Received Date: 05/31/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1