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

Model Number	H749CBM3400150
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that balloon detachment occurred.A 4.0 x 15 flextome cutting balloon was selected for use.During preparation, outside patient's body, the balloon came off with blue sheath covering the balloon.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.The balloon material was noted to have completed detached from the shaft of the device and was returned still within the blue balloon protective sheath.Multiple kinks were also noted along the length of the hypotube.Balloon material was noted to have completely detached from the shaft of the device and was returned still held within the blue balloon protective sheath.A visual and microscopic examination identified that the balloon material had completely detached from the shaft of the device.It detached from the device approximately 8mm proximal to the proximal edge of the proximal markerband.The balloon material was returned within the blue balloon protective sheath.The investigator removed the balloon material from the sheath.No issues were noted with the balloon material that could have contributed to the complaint incident.Visual and microscopic investigation identified no damage or any issues with the blades, tip or markerbands of the device that could have contributed to the complaint incident.All blades were present and fully bonded to the balloon material.Visual and tactile examination of the hypotube noted multiple kinks along its length.This type of damage is consistent with excessive force being applied to the delivery system.The balloon protector was received in position over the balloon.Due to the condition of the returned device it was not possible to apply a vacuum; however, the investigator removed the balloon protector sheath and slight resistance was encountered.The lack of vacuum may have resulted in the encountered resistance.The returned balloon protector inner dimension was verified at 0.0425 inch using a pin gauge and was within the specified range.No issues were identified that could have contributed to the complaint incident.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 or Problem Description
It was reported that balloon detachment occurred.A 4.0 x 15 flextome cutting balloon was selected for use.During preparation, outside patient's body, the balloon came off with blue sheath covering the balloon.There were 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: 7389309
• Report Number: 2134265-2018-02385
• Device Sequence Number: 679929
• Product Code: NWX
• UDI-Device Identifier: 08714729808480
• UDI-Public: 08714729808480
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 03/06/2018

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: 04/09/2020
• Device Model Number: H749CBM3400150
• Device Catalogue Number: CBM340015
• Device Lot Number: 20510124
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2018
• Initial Date Received by Manufacturer: 03/06/2018
• Supplement Date Received by Manufacturer: 04/19/2018
• Initial Report FDA Received Date: 04/02/2018
• Supplement Report FDA Received Date: 05/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1