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

Model Number	85020
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	06/10/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.".
Additional 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 or Problem 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
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 8784341
• Report Number: 2134265-2019-08105
• Device Sequence Number: 19432506
• Product Code: LPB
• UDI-Device Identifier: 08714729082439
• UDI-Public: 08714729082439
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P920047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Initial Date Received by Manufacturer: 06/19/2019
• Supplement Date Received by Manufacturer: 07/15/2019
• Initial Report FDA Received Date: 07/12/2019
• Supplement Report FDA Received Date: 07/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention