MAUDE Adverse Event Report: BIOSENSE WEBSTER INC WEBSTER¿ ELECTROPHYSIOLOGY CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Catalog Number	NS7TCD8L174HS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was discarded, therefore no product failure analysis can be conducted and device malfunction cannot be confirmed.We are working on the manufacture record evaluation (mre), once we get more information it will be submitted in the supplemental.Manufacture reference no: (b)(4).
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a webster¿ electrophysiology catheter and suffered heart block av 3rd degree requiring pacemaker implantation.During the procedure just before the transseptal puncture, heart block av 3rd degree was discovered and confirmed with electrocardiogram ecg.A temporary pacemaker was implanted.The patient was reported in stable condition after pacemaker implantation.The patient was then transferred to the intensive care unit icu and required an additional day of hospitalization for observation purposes.Patient¿s outcome was fully recovered with no residual effects and was discharged to home.The event happened before the ablation.There was no ablation catheter in the patient at the time of the event.Physician inserted a temporary pacing wire and paced the patient using the right ventricle (rv) catheter and proceeded with the case, which included left atrial ablation.No ablating was done near the conduction system.The catheters that were inside the patient¿s body at the time of the event were the rv (quadrapolar), coronary sinus cs (decapolar), and his bundle (octapolar) catheters.Physician¿s opinion regarding the cause of the adverse event is that it was procedure related.The physician believed the manipulation of the abbott sheath¿s j-wire bumped the conduction.No biosense webster inc.Product malfunctions were reported.
Additional Manufacturer Narrative
It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a webster¿ electrophysiology catheter and suffered heart block av 3rd degree requiring pacemaker implantation.This complaint was submitted in error as the event is not mdr reportable.During an internal review, it was discovered that the webster¿ electrophysiology catheter was not the suspected device.Physician¿s opinion regarding the cause of the adverse event is that it was procedure related.The physician believed the manipulation of the abbott sheath¿s j-wire bumped the conduction.No biosense webster inc.Product malfunctions were reported.Additional information was received indicating the event occurred before the ablation and that no ablation catheter was in the patient at the time of the event.There is no clear evidence that the webster¿ electrophysiology catheter was directly related to the atrioventricular block complete requiring pacemaker implantation.However, since it has already been reported to fda, any additional updates received will continue to be reported.Manufacture reference no: pc-000499667.

• Brand Name: WEBSTER¿ ELECTROPHYSIOLOGY CATHETER
• Common Device Name: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 8853061
• Report Number: 2029046-2019-03486
• Device Sequence Number: 1561560
• Product Code: OAD
• UDI-Device Identifier: 10846835000580
• UDI-Public: 10846835000580
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P010068
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/02/2021
• Device Catalogue Number: NS7TCD8L174HS
• Device Lot Number: 30155453M
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/08/2019
• Supplement Date Received by Manufacturer: 08/14/2019
• Initial Report FDA Received Date: 08/01/2019
• Supplement Report FDA Received Date: 08/14/2019
• 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: Hospitalization; Required Intervention