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 11/07/2019

Event Type  malfunction  

Event Description

It was reported that the delivery shaft was fractured.The target lesion was in the calcified left coronary artery.A 06/3.00 flextome cutting balloon was selected for use.During the procedure, it was noted that the delivery shaft was fractured inside patient.The device was then directly and completely removed from the patient's body without any intervention.The procedure was completed with another of the same device.No complications were reported and patient was stable.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.The device was received in two sections as a result of a complete breaks of the hypotube.A visual and tactile examination a complete break in the hypotube of the device.The break was located at approximately 415mm distal of the strain relief.The hypotube was also noted to be kinked at more than one location.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.

Event Description

It was reported that the delivery shaft was fractured.The target lesion was in the calcified left coronary artery.A 06/3.00 flextome cutting balloon was selected for use.During the procedure, it was noted that the delivery shaft was fractured inside patient.The device was then directly and completely removed from the patient's body without any intervention.The procedure was completed with another of the same device.No complications were reported and patient 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: 9377245
• MDR Text Key: 173772365
• Report Number: 2134265-2019-14461
• 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: 01/14/2020

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: 07/15/2021
• Device Model Number: 3820
• Device Catalogue Number: 3820
• Device Lot Number: 0022378325
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2019
• Initial Date Manufacturer Received: 11/11/2019
• Initial Date FDA Received: 11/26/2019
• Supplement Dates Manufacturer Received: 01/03/2020
• Supplement Dates FDA Received: 01/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 70