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

Model Number 3820

Device Problem Break (1069)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/22/2020

Event Type  malfunction  

Event Description

It was reported that the delivery shaft was fractured.The target lesion area was located in the front end of the right coronary artery.A 06/3.50 flextome cutting balloon was selected for use in a percutaneous coronary intervention.During preparation, it was noted that the delivery shaft was fractured and it could not be used.The fracture occurred outside of the patient's body.The procedure was completed with another of the same device.There were no complications reported, and the 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 break in the hypotube.Based on potential hazards identified, the following attributes were considered during analysis: a visual examination identified that the balloon was unfolded.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.The device was received in two sections as a result of a break in the hypotube.The break was located at 44.3cm distal from the strain relief.This type of damage is consistent with excessive force that could have been applied to the delivery system.No kinks or damages were observed along the length of the extrusion.

Event Description

It was reported that the delivery shaft was fractured.The target lesion area was located in the front end of the right coronary artery.A 06/3.50 flextome cutting balloon was selected for use in a percutaneous coronary intervention.During preparation, it was noted that the delivery shaft was fractured and it could not be used.The fracture occurred outside of the patient's body.The procedure was completed with another of the same device.There were no complications reported, and the 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: 11127465
• MDR Text Key: 225491947
• Report Number: 2134265-2020-18590
• 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: 02/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: 3820
• Device Catalogue Number: 3820
• Device Lot Number: 0024696945
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2021
• Date Manufacturer Received: 02/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Weight: 61