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

Model Number 3820

Device Problem Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/07/2021

Event Type  malfunction  

Manufacturer Narrative

The device was returned for analysis.A visual and microscopic examination of the balloon found the wings to be tightly wrapped and had not been subjected to positive pressure.The balloon and blades of the device were visually and microscopically examined, and no issues were noted that may have potentially contributed to the complaint incident.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 marker bands.The device was received in two sections as a result of a break in the hypotube.The break was located at 70cm distal from the strain relief.The proximal section of the hypotube was kinked at various locations.

Event Description

Reportable based on device analysis completed on 02apr2021.It was reported that the catheter shaft was kinked.The 92% stenosed, 6mmx2.5mm, target lesion was located in moderately tortuous and moderately calcified left anterior descending artery.A 06/2.50 flextome cutting balloon was selected for use.During the procedure, it was noted that the balloon delivery shaft was kinked 70cm away from the distal end of the balloon.The procedure was completed with another of the same device.There were no patient complications reported and the patient status was stable.However device analysis revealed a shaft break.

• 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
• Manufacturer (Section G): BOSTON SCIENTIFIC IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 11668809
• MDR Text Key: 245507169
• Report Number: 2134265-2021-04726
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/08/2022
• Device Model Number: 3820
• Device Catalogue Number: 3820
• Device Lot Number: 0024240155
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/02/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 63