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

Catalog Number	D7DR252RT
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Tamponade (2226); No Code Available (3191)
Date of Event	12/11/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No device was received for analysis at the time of submission of the initial 3500a.Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.The device history record (dhr) for the lot number 17704276m has been reviewed and it was verified that the device was manufactured in accordance with documented specifications and procedures.Concomitant product: carto 3 system, us catalog: fg540000, serial #: (b)(4).Smartablate generator, us catalog: m490007, serial #: (b)(4).Smartablate pump, us catalog #: m490008, serial #: (b)(4).Non biosense webster, inc.- st.Jude medical brk 71 cm transseptal needle.Non biosense webster, inc.- st.Jude medical slo 8.5 french long sheath.(b)(4).
Event or Problem Description
Originally, this event was reported under the thermocool smarttouch bidirectional sf catheter.However, additional information was received on january 25, 2018 providing the right ventricle (rv) catheter product information of webster¿ electrophysiology catheter.Therefore, since the physician¿s opinion regarding the cause of the adverse event is that there was a possible perforation while advancing the rv catheter into the rv, it has been assessed to also report this event under the webster¿ electrophysiology catheter.The awareness date is january 25, 2018 for this report.It was reported that an (b)(6) female patient underwent an ablation procedure for ventricular tachycardia with a webster¿ electrophysiology catheter and thermocool smarttouch bidirectional sf catheter and suffered a cardiac tamponade requiring pericardiocentesis and surgical intervention.After transseptal puncture and after mapping with the thermocool smarttouch bidirectional sf catheter, but prior to any ablation, the patient became hypotensive.Pericardial effusion was confirmed via ultrasound.Pericardiocentesis yielded 1000 ml of fluid.Patient was sent for a surgical repair to patch the right ventricular (rv) tear.Patient required extended hospitalization as a result of the adverse event for surgical recovery.Patient fully recovered.There were no patient factors cited that may have contributed to the adverse event.Physician¿s opinion regarding the cause of the adverse event is that there was a possible perforation while advancing the rv catheter (webster¿ electrophysiology catheter) into the rv.Transseptal puncture was performed with a st.Jude medical brk 71 cm transseptal needle and a st.Jude medical slo 8.5 french long sheath.There is no information regarding generator parameters, generator settings, power titration, overall ablation time at the site of injury, or last ablation cycle time at the site of injury, as no ablation was performed.There is no information regarding irrigated catheter flow setting.Patient received anticoagulant (heparin) during the procedure with activated clotting time (act) between 300-320 seconds.During the procedure, the carto 3 system c-arm hit the location pad and broke off a screw (mp470324) and guiding pin (ma540309).There is no information regarding shaft proximity interference value.Thermocool smarttouch bidirectional sf catheter was not in close proximity to another catheter.Thermocool smarttouch bidirectional sf 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 errors reported on any biosense webster, inc.Equipment during the procedure.Since this adverse event required medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious and mdr reportable.

• Brand Name: WEBSTER¿ ELECTROPHYSIOLOGY CATHETER
• Common Device Name: CATHETER, ELECTRODE RECORDING
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 7284743
• Report Number: 2029046-2018-01114
• Device Sequence Number: 143580
• Product Code: DRF
• UDI-Device Identifier: 10846835005646
• UDI-Public: 10846835005646
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 12/11/2017

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: 06/30/2020
• Device Catalogue Number: D7DR252RT
• Device Lot Number: 17704276M
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/11/2017
• Initial Report FDA Received Date: 02/20/2018
• 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: 80 YR