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

Model Number 3822

Device Problems Leak/Splash (1354); Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/22/2020

Event Type  malfunction  

Event Description

It was reported that a balloon leak occurred.The 26mm x 4.0mm concentrically shaped target lesion was located in the non tortuous and severely calcified left anterior descending artery.A 10/3.50 flextome cutting balloon was selected for use.During procedure, the balloon was inflated three times at 9atm, 10atm and 11atm accordingly within 10 seconds each time.However, the balloon was unable to inflate fully.The balloon was deflated and removed from the patient completely.There was significant resistance during advancement and withdrawal.It was found out that the balloon was leaking.The procedure was completed with this device.No patient complications were reported and patient was stable post procedure.

Manufacturer Narrative

Device evaluated by mfr: the device was returned for evaluation.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.The device was attached to an inflation device, subjected to positive pressure and liquid was observed to be leaking from a balloon pinhole located approximately 1mm proximal of the distal markerband.The rated burst pressure for this device is 12 atmospheres.An examination of the balloon material and markerbands identified no issues which could potentially have contributed to this complaint.A visual and microscopic examination observed no damage to the tip, markerbands or blades.All blades were present and fully bonded to the balloon surface.No kinks or damage were noted along the shaft of the device.No other issues were identified during the product analysis.

Event Description

It was reported that a balloon leak occurred.The 26mmx4.0mm concentrically shaped target lesion was located in the non tortuous and severely calcified left anterior descending artery.A 10/3.50 flextome cutting balloon was selected for use.During procedure, the balloon was inflated three times at 9atm, 10atm and 11atm accordingly within 10 seconds each time.However, the balloon was unable to inflate fully.The balloon was deflated and removed from the patient completely.There was significant resistance during advancement and withdrawal.It was found out that the balloon was leaking.The procedure was completed with this device.No patient complications were reported and patient was stable post procedure.

• 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: 10627600
• MDR Text Key: 209810447
• Report Number: 2134265-2020-13669
• 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: 11/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/18/2021
• Device Model Number: 3822
• Device Catalogue Number: 3822
• Device Lot Number: 0022270580
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2020
• Date Manufacturer Received: 11/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 80 YR