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

Model Number 3822

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 08/11/2020

Event Type  malfunction  

Event Description

It was reported that the shaft was fractured.A 10/2.50 flextome cutting balloon was selected for use.Upon unpacking, it was noted that the shaft was fractured.The procedure was completed with another of the same device.There were no complications reported and the patient was stable post procedure.

Event Description

It was reported that the shaft was fractured.A 10/2.50 flextome cutting balloon was selected for use.Upon unpacking, it was noted that the shaft was fractured.The procedure was completed with another of the same device.There were no complications reported and the patient was stable post procedure.

Manufacturer Narrative

Device evaluated by mfr: the device was returned for analysis.A visual and tactile examination identified that the hypotube was kinked at more than one location and the shaft polymer extrusion was kinked at the guidewire port.This type of damage is consistent with excessive force being applied to the delivery system.A visual examination identified that the balloon was not subjected to positive pressure.An examination of the balloon identified no issues which could potentially have contributed to this complaint.A visual and microscopic examination identified no damage to the tip, markerbands or blades of the device.All blades were present and fully bonded to the balloon material.No other issues were identified during the product 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: 10482602
• MDR Text Key: 205306988
• Report Number: 2134265-2020-12156
• 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
• Report Date: 10/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/10/2023
• Device Model Number: 3822
• Device Catalogue Number: 3822
• Device Lot Number: 0025190355
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2020
• Date Manufacturer Received: 09/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 82 YR
• Patient Weight: 80