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

Model Number 3822

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/04/2020

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.

Event Description

It was reported that the balloon blade was loose.The target lesion was located in the severely calcified left anterior descending artery.A 10/3.00 flextome cutting balloon was selected for use.During the procedure, it was noted that the blade on the balloon was loose and could not cut the plaque.The device was pulled out within the catheter from the patient.The balloon was completely removed from the patient's body and the procedure was completed with a different device.No complications reported and the patient was stable post procedure.

Event Description

It was reported that the balloon blade was loose.The target lesion was located in the severely calcified left anterior descending artery.A 10/3.00 flextome cutting balloon was selected for use.During the procedure, it was noted that the blade on the balloon was loose and could not cut the plaque.The device was pulled out within the catheter from the patient.The balloon was completely removed from the patient's body and the procedure was completed with a different device.No complications reported and the patient was stable post procedure.It was further reported that the balloon was inflated once and scored the lesion when the loose blade was noticed.

Manufacturer Narrative

A2 - age at time of event: 18 years or older.

• 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: 10547056
• MDR Text Key: 207335251
• Report Number: 2134265-2020-12868
• 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: 10/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/11/2020
• Device Model Number: 3822
• Device Catalogue Number: 3822
• Device Lot Number: 0021124225
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1