MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION BLAZER II; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number 85020

Device Problem Difficult to Remove (1528)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/10/2019

Event Type  Injury  

Manufacturer Narrative

It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.

Event Description

It was reported that the device was difficult to withdraw.During an ablation procedure for wolff-parkinson-white (wpw) syndrome, ablation was performed of the left atrium mitral valve annulus with a blazer ii catheter.The procedure was started by approaching from the aorta.When the catheter was removed from the left atrium after completing the ablation, the tip of the catheter was tangled with the a valve chord and it became unable to remove.The catheter was planned to be removed by surgical thoracotomy.With regards to catheter removal surgically, the catheter could not be removed from the "ao side", but the catheter could be removed by pulling it out from the ventricular side.It was also reported that the device "remained inside" the patient.The procedure was cancelled.The patient was "still alive.".

Manufacturer Narrative

It was indicated that the device will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.

Event Description

It was reported that the device was difficult to withdraw.During an ablation procedure for wolff-parkinson-white (wpw) syndrome, ablation was performed of the left atrium mitral valve annulus with a blazer ii catheter.The procedure was started by approaching from the aorta.When the catheter was removed from the left atrium after completing the ablation, the tip of the catheter was tangled with the a valve chord and it became unable to remove.The catheter was planned to be removed by surgical thoracotomy.With regards to catheter removal surgically, the catheter could not be removed from the "ao side", but the catheter could be removed by pulling it out from the ventricular side.It was also reported that the device "remained inside" the patient.The procedure was cancelled.The patient was "still alive." it was further reported that the device was surgically removed.The patient's outcome was good.

• Brand Name: BLAZER II
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 8784341
• MDR Text Key: 150817510
• Report Number: 2134265-2019-08105
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 08714729082439
• UDI-Public: 08714729082439
• Combination Product (y/n): N
• PMA/PMN Number: P920047
• 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: 07/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/25/2020
• Device Model Number: 85020
• Device Catalogue Number: 85020
• Device Lot Number: 0020333983
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention