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

Model Number	3822
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.
Event or Problem Description
It was reported that the balloon broke.A 10/4.00 flextome cutting balloon was selected for use.During the procedure, it was noted that the balloon broke and the wire came out from the balloon.The procedure was completed with another of same device.No patient complications were reported.
Additional Manufacturer Narrative
Age at time of event: 18 years or older.
Event or Problem Description
It was reported that the balloon broke.A 10/4.00 flextome cutting balloon was selected for use.During the procedure, it was noted that the balloon broke and the wire came out from the balloon.The procedure was completed with another of same device.No patient complications were reported.Device evaluated by manufacturer: the device was returned for analysis.Product analysis identified that the shaft polymer extrusion was completely detached from the distal tip bond.The balloon and blades of the device were visually and microscopically examined and no issues were noted that may have potentially contributed to the complaint incident.A microscopic examination identified that the shaft was completely detached at the shaft to distal tip bond.This type of damage is consistent with excessive tensile force being applied when attempting to remove the balloon protector without applying a sufficient vacuum to the device.A visual and microscopic investigation identified no damage or any issues with the markerbands of the device that could have contributed to the complaint incident.A visual and tactile examination identified no issues with the hypotube of the device that could have contributed to the complaint incident.No other issues were identified during the product analysis.

• Brand Name: FLEXTOME CUTTING BALLOON
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 7874642
• Report Number: 2134265-2018-60669
• Device Sequence Number: 11281798
• Product Code: NWX
• UDI-Device Identifier: 08714729808398
• UDI-Public: 08714729808398
• Combination Product (Y/N): N
• PMA/510(K) Number: P950020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2018

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: 05/25/2020
• Device Model Number: 3822
• Device Catalogue Number: 3822
• Device Lot Number: 0020696551
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2018
• Initial Date Received by Manufacturer: 08/16/2018
• Supplement Date Received by Manufacturer: 09/24/2018
• Initial Report FDA Received Date: 09/13/2018
• Supplement Report FDA Received Date: 10/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1