MAUDE Adverse Event Report: BIOSENSE WEBSTER INC EZ STEER¿ BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER; ELECTRODE, PERCUTANEOUS, CONDUCTION TISSUE ABLATION

Catalog Number	BD7TCDF4L
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Arrhythmia (1721); No Code Available (3191)
Date of Event	02/15/2018
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.Since no lot number was provided, no device history record (dhr) review could be performed.Concomitant products: carto 3 system (model# unknown serial# unknown).(b)(4).
Event or Problem Description
It was reported that a (b)(6) female patient underwent an ablation procedure for supraventricular tachycardia (svt) with an ez steer¿ bi-directional electrophysiology catheter and suffered a heart block requiring surgical intervention.Electrophysiology testing revealed atrioventricular nodal reentrant tachycardia (avnrt).Mapping was performed with fast anatomical map (fam) geometry and bipolar electrical mapping on the endocardial areas of interest.His bundle was located and denoted with markers on the endocardial map.During the final ablation, three beats of atrioventricular (av) dissociation were observed on electrograms and confirmed via echocardiogram (ecg).Ablation was stopped immediately.Heart block 2nd degree type ii displayed on the monitor.Intravenous solumedrol was administered and patient was observed for 40 minutes, during which time the heart block converted from 2nd degree type ii to 2nd degree type i.A temporary pacemaker was inserted.Patient was admitted to the facility for overnight observation.At an unspecified point post-procedure, a permanent pacemaker was implanted.Patient required extended hospitalization as a result of the adverse event.There is no information regarding patient outcome.Review of the electrograms and ecgs (ge recording system and carto replay) revealed no his signals during ablation and no junctional beats preceding the heart block.Patient converted from normal sinus rhythm directly to heart block.Carto measurement of the last ablation point closest to the his bundle signal was 11 mm.Physician initially assumed that the compact av node may have been stressed by edema from the ablated tissue.Physician¿s opinion regarding the cause of the adverse event is that it was procedure-related.It was noted that the catheters used for this procedure all performed as expected and without malfunctions.There were no issues or errors reported with any bwi products or equipment during the procedure.

• Brand Name: EZ STEER¿ BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER
• Common Device Name: ELECTRODE, PERCUTANEOUS, CONDUCTION TISSUE ABLATION
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 7336699
• Report Number: 2029046-2018-01298
• Device Sequence Number: 11157304
• Product Code: LPB
• UDI-Device Identifier: 10846835002515
• UDI-Public: 10846835002515
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P950005/S19
• 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): 02/15/2018

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: BD7TCDF4L
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/15/2018
• Initial Report FDA Received Date: 03/13/2018
• 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: 67 YR