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

Model Number 3820

Device Problem Leak/Splash (1354)

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

Event Date 08/05/2021

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.

Event Description

Reportable based on additional information received on 30aug2021.It was reported that the balloon was leaking gas.The 90% stenosed target lesion was located in the mildy tortuous and severely calcified left main coronary artery.A 06/3.75 flextome cutting balloon was selected for use.During the procedure, it was noted that the balloon was leaking gas.The procedure was completed with another of the same device.No patient complications reported.However, additional information reveals that the balloon burst.

Event Description

Reportable based on additional information received on 30aug2021.It was reported that the balloon was leaking gas.The 90% stenosed target lesion was located in the mildy tortuous and severely calcified left main coronary artery.A 06/3.75 flextome cutting balloon was selected for use.During the procedure, it was noted that the balloon was leaking gas.The procedure was completed with another of the same device.No patient complications reported.However, additional information reveals that the balloon burst.

Manufacturer Narrative

Age at time of event: 18 years or older.Device evaluated by manufacturer: the device was returned for analysis.A visual examination identified that the balloon was returned with it balloon folds intact.No tears or holes were visible in the balloon.The returned device was attached to an encore inflation unit and positive pressure was applied in an attempt to inflate the balloon.A pinhole was identified in the balloon material at 1mm proximal to the distal marker band.An examination of the marker bands identified no issues which could potentially have contributed to this complaint.All blades were fully bonded onto the balloon with no issues identified.No issues were noted with the tip section of the device.A visual and microscopic examination found no issue with the marker bands.A visual and tactile examination found no issues.

• Brand Name: FLEXTOME CUTTING BALLOON
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• MDR Report Key: 12448271
• MDR Text Key: 270615811
• Report Number: 2134265-2021-11473
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 11/04/2021

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: 08/22/2021
• Device Model Number: 3820
• Device Catalogue Number: 3820
• Device Lot Number: 0022555289
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2021
• Initial Date Manufacturer Received: 08/20/2021
• Initial Date FDA Received: 09/09/2021
• Supplement Dates Manufacturer Received: 10/14/2021
• Supplement Dates FDA Received: 11/04/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/23/2018
• 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