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

Model Number 3820

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/25/2020

Event Type  malfunction  

Event Description

It was reported that the device was fractured.A 06/2.75 flextome cutting balloon was selected for use.Upon unpacking, it was noted that the device was fractured in the middle.The procedure was completed with another of the same device.No complications reported and patient was stable post procedure.

Event Description

It was reported that the device was fractured.A 06/2.75 flextome cutting balloon was selected for use.Upon unpacking, it was noted that the device was fractured in the middle.The procedure was completed with another of the same device.No complications reported and patient was stable post procedure.It was further reported that the balloon and shaft extrusion portion of the device that was not returned, were confirmed to be discarded in the facility.The device was completely removed from the patient's body.

Event Description

It was reported that the device was fractured.A 06/2.75 flextome cutting balloon was selected for use.Upon unpacking, it was noted that the device was fractured in the middle.The procedure was completed with another of the same device.No complications reported and patient was stable post procedure.It was further reported that the balloon and shaft extrusion portion of the device that was not returned, were confirmed to be discarded in the facility.The device was completely removed from the patient's body.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.A visual examination identified that the balloon was tightly folded.No damage or any issues were noted with the balloon material that could have contributed to the complaint incident.The markerbands and blades and tip section of the device were visually and microscopically examined, and no issues were noted with the markerbands, blades or tip of the device.All blades were present and fully bonded to the balloon material.A visual and tactile examination found that the device was returned without the shaft polymer extrusion and balloon portion of the device.72.3cm of device was returned (from strain relief to break point).Multiple kinks were also noted along several locations of the hypotube shaft.This type of damage is consistent with excessive force that could have been applied to the delivery system.The shaft polymer extrusion section of the device was not returned for analysis.

• 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: 10992167
• MDR Text Key: 220937954
• Report Number: 2134265-2020-17320
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 01/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/07/2023
• Device Model Number: 3820
• Device Catalogue Number: 3820
• Device Lot Number: 0025003971
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2020
• Date Manufacturer Received: 01/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Weight: 71