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

Model Number 3820

Device Problems Material Deformation (2976); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/13/2019

Event Type  malfunction  

Manufacturer Narrative

Age at the time of event: 18 years or older.

Event Description

It was reported that the coating of the delivery shaft peeled off.The target lesion was located in a coronary vessel.A 06/3.25 flextome cutting balloon was selected for use.During procedure, it was noted that the proximal and middle part of the delivery shaft of the device was kinked and the coating on proximal part was peeled off.The procedure was completed with another of the same device.No patient complications reported and the patient's condition was stable.

Manufacturer Narrative

Age at time of event: 18 years or older.Device evaluated by manufacturer.The device was return for analysis.An examination of the returned device identified that the balloon had been inflated and was not refolded.It is not known when the balloon was subjected to positive pressure.No issues were identified with balloon of the returned device.A visual and microscopic examination observed no damage to the blades.All blades were present and fully bonded to the balloon surface.No issues were noted with the tip section of the device.A visual and microscopic examination found no issue with the markerbands.A visual and tactile examination found that the hypotube to be severely kinked at several locations along its length.No peeling of the coating on the hypotube was identified.No other issues were noted which may have potentially contributed to the complaint incident.No other issues were identified during the product analysis.

Event Description

It was reported that the coating of the delivery shaft peeled off.The target lesion was located in a coronary vessel.A 06/3.25 flextome cutting balloon was selected for use.During procedure, it was noted that the proximal and middle part of the delivery shaft of the device was kinked and the coating on proximal part was peeled off.The procedure was completed with another of the same device.No patient complications reported and the patient's' condition was stable.

• Brand Name: FLEXTOME CUTTING BALLOON
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8404107
• MDR Text Key: 138253307
• Report Number: 2134265-2019-02213
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• PMA/PMN Number: P950020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 04/17/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 01/11/2021
• Device Model Number: 3820
• Device Catalogue Number: 3820
• Device Lot Number: 0021605227
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2019
• Initial Date Manufacturer Received: 02/13/2019
• Initial Date FDA Received: 03/08/2019
• Supplement Dates Manufacturer Received: 03/29/2019
• Supplement Dates FDA Received: 04/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1