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

Catalog Number	F6QD005RT
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	01/21/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The bwi product analysis lab received the device for evaluation.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.On 2/4/2019, a manufacturing record evaluation was performed for the finished device 30086654m number, and no non-conformances related to the reported complaint condition were identified.Concomitant products: thermocool® smart touch¿ bi-directional navigation catheter (d132705/ 30086654m).Cook transseptal needle (model# unknown, lot# unknown).Carto 3 system (model# unknown, serial # unknown).Manufacture reference no: (b)(4).
Event or Problem Description
It was reported that a (b)(6) female patient underwent a premature ventricular contraction (pvc) ablation procedure with a webster¿ electrophysiology catheter and suffered cardiac tamponade requiring pericardiocentesis.Post-procedure, while the patient was in recovery, blood pressure dropped.Cardiac tamponade was confirmed by echocardiogram.The patient was moved back to the lab.Pericardiocentesis was performed to remove an unspecified amount of fluid from the pericardium.After pericardial puncture, the patient was reported to be in stable condition and was transferred to intensive care unit (icu) for observation purposes.Patient¿s outcome was recovered.Physician¿s opinion regarding the cause of the adverse event is that it was procedure-related and caused by the webster¿ electrophysiology catheter.Physician suspects that the webster¿ electrophysiology catheter perforated the right ventricle (rv) wall and tamponade occurred after the catheter was removed from the body.No error messages were observed on any biosense webster inc.(bwi) equipment during the procedure.Transseptal puncture was performed with a cook transseptal needle.The generator was in power control mode.The catheter irrigation was set at 17-30 ml/min.The thermocool® smart touch¿ bi-directional navigation catheter was not in close proximity to another catheter and it was zeroed after the initial warm-up phase post catheter connection to the carto 3 patient interface unit.The carto 3 did not indicate to re-zero the catheter.
Additional Manufacturer Narrative
It was reported that a 70-year-old female patient underwent a premature ventricular contraction (pvc) ablation procedure with a webster¿ electrophysiology catheter and suffered cardiac tamponade requiring pericardiocentesis.The investigational analysis completed 2/26/2019.The device was visually inspected and it was found in good conditions.Electrical testing was performed on the catheter and it was found within specifications.No electrical malfunction was observed.Deflection testing was performed and it was found within specifications.The catheter was deflecting correctly.A manufacturing record evaluation was performed and no internal actions related to the reported complaint were identified.The catheter passed all specifications.The root cause of the adverse event remains unknown.The instructions for use state that careful catheter manipulation must be performed to avoid cardiac damage, perforation or tamponade.Manufacture reference no: (b)(4).

• 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: 8340655
• Report Number: 2029046-2019-02687
• Device Sequence Number: 11319986
• Product Code: LDF
• UDI-Device Identifier: 10846835007923
• UDI-Public: 10846835007923
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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,Followup
• Report Date (Section B): 01/21/2019

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: 09/12/2021
• Device Catalogue Number: F6QD005RT
• Device Lot Number: 30122359M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2019
• Initial Date Received by Manufacturer: 01/21/2019
• Supplement Date Received by Manufacturer: 02/26/2019
• Initial Report FDA Received Date: 02/14/2019
• Supplement Report FDA Received Date: 03/20/2019
• 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
• Patient Age: 70 YR