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

Model Number 3822

Device Problem Inflation Problem (1310)

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

Event Date 03/17/2021

Event Type  malfunction  

Manufacturer Narrative

A visual examination of the returned device identified no tears or holes in the balloon material.The returned device was attached to a boston scientific encore inflation unit.Positive pressure was applied and the balloon was successfully inflated to its rate rated burst pressure.The pressure held for 30 seconds without issue and a vacuum was then applied.This was repeated three times with no leaks or drop in pressure noted.No issues were identified with balloon inflation or the balloon material.A visual examination identified that <1mm of a blade was missing from the proximal end of a distal section of the blade strip.The pad was intact.No other damage was identified to the remaining blades.A visual and tactile examination found no kinks.No issues were noted with the tip section of the device.A visual and microscopic examination found no issue with the marker bands.

Event Description

Reportable based on device analysis completed on 13may2021.It was reported that inflation failure occurred.Vascular access was obtained though femoral artery.The 60% stenosed target lesion area was located in the mildly tortuous and mildly calcified left anterior descending artery (lad).A 10/3.00 flextome cutting balloon was introduced, however, the balloon was unable to be inflated.The procedure was completed with another of the same device.There were no complications reported and the patient was stable.However, device analysis revealed part of a blade was detached.

• 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: 11915834
• MDR Text Key: 254143423
• Report Number: 2134265-2021-07091
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P950020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/01/2021

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: 07/23/2022
• Device Model Number: 3822
• Device Catalogue Number: 3822
• Device Lot Number: 0024157627
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/13/2021
• Initial Date FDA Received: 06/01/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/24/2019
• 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