MAUDE Adverse Event Report: BIOSENSE WEBSTER INC. WEBSTER¿ ELECTROPHYSIOLOGY CATHETER; CATHETER, ELECTRODE RECORDING OR PROBE, ELECTRODE RECORDING

Catalog Number	UNKNOWN
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	05/21/2018
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.Device history record (dhr) review cannot be conducted because no lot number was provided by the customer.Concomitant bwi products: webster¿ electrophysiology catheters (catalog # unknown, and lot # unknown).Thermocool® smart touch® sf bi-directional navigation catheter (catalog # d134701, lot # 17752329l).Carto 3 system (catalog # fg540000, serial (b)(4)).Smartablate pump (catalog # m490008,serial (b)(4)).Smartablate generator (catalog # m490007, serial (b)(4)).
Event or Problem Description
It was reported that a (b)(6) female patient underwent an idiopathic ventricular tachycardia ablation procedure for premature ventricular contractions (pvcs) with two (2) webster¿ electrophysiology catheters and suffered a cardiac tamponade requiring pericardiocentesis.Toward the end of the procedure, the patient became hypotensive.Pericardial effusion was detected via echocardiography.Pericardiocentesis yielded an unspecified volume of fluid.Patient required extended hospitalization (4 additional nights) as a result of the adverse event for monitoring.There were no patient factors cited that may have contributed to the adverse event.Patient fully recovered with no residual effects and was discharged to home.It was noted that the injury occurred mid to post-ablation.Physician¿s opinion regarding the cause of the adverse event is that it was related to the webster¿ electrophysiology catheter.There were no issues, errors, or malfunctions reported on any bwi products or equipment during the procedure.No transseptal puncture was performed, as transseptal access was obtained via a patent foramen ovale (pfo).There is no sheath information.Generator was set on power control mode at 35 watts, time of 999 seconds, temperature of 24 degrees celsius, and impedance of 120 ohms.Power was not titrated during ablation.Overall ablation time at the site of injury was 2 minutes and 50 seconds.There is no information regarding last ablation cycle time.Irrigated catheter flow was set on 2 ml/min.Patient received anticoagulant during the procedure with activated clotting time (act) maintained in an unspecified range.There is no information regarding spi value.The thermocool® smart touch® sf bi-directional navigation catheter was not in close proximity to another catheter during the procedure.The thermocool® smart touch® sf bi-directional navigation catheter was zeroed after the initial warm-up phase, post catheter connection to the carto 3 patient interface unit.Carto 3 system did not indicate to re-zero the catheter.There were no issues, errors, or malfunctions reported on any bwi products or equipment during the procedure.

• Brand Name: WEBSTER¿ ELECTROPHYSIOLOGY CATHETER
• Common Device Name: CATHETER, ELECTRODE RECORDING OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 33 technology drive; irvine CA 92618
• MDR Report Key: 7615702
• Report Number: 2029046-2018-01694
• Device Sequence Number: 11237260
• Product Code: DRF
• UDI-Device Identifier: 10846835007978
• UDI-Public: 10846835007978
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 05/21/2018

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: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/21/2018
• Initial Report FDA Received Date: 06/19/2018
• 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: 84 YR