MAUDE Adverse Event Report: BIOSENSE WEBSTER INC. WEBSTER ELECTROPHYSIOLOGY CATHETER; ELECTRODE, PACEMAKER, TEMPORARY

Catalog Number	F6QF002RT
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	06/06/2019
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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacture record evaluation (mre) review cannot be conducted because no lot number was provided by the customer.Biosense webster manufacturer's reference number (b)(4) has two reports related to the same event: mfr # 2029046-2019-03368 for product code ns7tcd8l174hs (navistar¿ ds electrophysiology catheter); this mfr # for product code f6qf002rt (webster¿ electrophysiology catheter).
Event or Problem Description
It was reported that a (b)(6) female patient ((b)(6)) underwent an atrial fibrillation (afib) ablation procedure with a navistar¿ ds electrophysiology catheter and a webster¿ electrophysiology catheter and suffered cardiac tamponade requiring pericardiocentesis.After the case was over, and they were preparing to pull the sheaths the patient¿s blood pressure dropped, and cardiac tamponade was confirmed by transthoracic echo (tee).Pericardiocentesis was performed to remove 250cc of fluid from the pericardial space.The patient was reported in stable condition after pericardial drainage.The patient stayed an extra day for observation purposes.Patient¿s outcome is improved.Physician¿s opinion regarding the cause of the adverse event is that it was procedure-related, physician believes the issue was caused by webster rv catheter manipulation near the end of the procedure, (after the ablation part of the procedure was over) due to non-capture and felt that the repositioning of the rv catheter resulted in the injury.He mentioned that he thinks this catheter is stiffer than some others, and that the patient¿s anatomy (thinner ventricle) might have also contributed to the adverse event.Transseptal puncture was performed with a st.Jude medical bk-1 needle.There was no evidence of steam pop.No bwi product malfunctions were reported during the case.This event will be reported under both products since the issue occurred after the ablation was concluded; therefore, it cannot be determined the issue was not related to radiofrequency (rf) delivery.

• Brand Name: WEBSTER ELECTROPHYSIOLOGY CATHETER
• Common Device Name: ELECTRODE, PACEMAKER, TEMPORARY
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 33 technology drive; irvine CA 92618
• MDR Report Key: 8746943
• Report Number: 2029046-2019-03369
• Device Sequence Number: 19432551
• Product Code: LDF
• UDI-Device Identifier: 10846835007961
• UDI-Public: 10846835007961
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K892265
• 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
• Report Date (Section B): 06/06/2019

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 Catalogue Number: F6QF002RT
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/06/2019
• Initial Report FDA Received Date: 06/30/2019
• 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: Hospitalization; Life Threatening; Required Intervention