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

Catalog Number NS7TCDL174HS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Complete Heart Block (2627)

Event Date 08/17/2018

Event Type  Injury  

Manufacturer Narrative

The product was discarded, therefore no product failure analysis can be conducted and device malfunction cannot be confirmed.The device history record (dhr) was reviewed and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.Concomitant: carto 3 system (model# unknown,serial# unknown), manufacture reference no: (b)(4).

Event Description

It was reported that a patient underwent an ablation procedure and an unspecified device issue occurred.No adverse patient consequences were reported.Multiple attempts had been made to obtain clarification to this complaint.However, no further information had been made available.This complaint was initially assessed as not reportable as clarification of the event was needed.On (b)(6) 2018, additional information was received.It was reported that a (b)(6) female patient underwent an ablation procedure for atrioventricular nodal reentry tachycardia (avrnt) with a navistar¿ electrophysiology catheter and suffered heart block atrioventricular.During the procedure, the physician placed the ablation catheter in an anatomical difficult location which made the catheter fixation difficult.When ablating the coronary sinus for several seconds, it was confirmed with univu that the catheter moved, and the patient developed heart block atrioventricular.Pacing was performed but the issue continued.The remainder of the procedure was aborted.A pacemaker is planned to be implanted.There¿s no information regarding extended hospitalization.Patient¿s outcome was improved.Physician¿s opinion regarding the cause of the adverse event is that it was procedure related.The physician did not attribute the causality of the adverse event to the biosense webster, inc.Product.The clarification received stating that the patient suffered a heart block atrioventricular has been assessed as a serious injury.The awareness date was reset to (b)(6) 2018.

• Brand Name: NAVISTAR¿ ELECTROPHYSIOLOGY
• Type of Device: CATHETER, ELECTRODE RECORDING
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: gabriel alfageme ; 33 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 8116178
• MDR Text Key: 128887029
• Report Number: 2029046-2018-02380
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 10846835000597
• UDI-Public: 10846835000597
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P990025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/17/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 04/19/2021
• Device Catalogue Number: NS7TCDL174HS
• Device Lot Number: 30050018M
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/01/2018
• Initial Date FDA Received: 11/29/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR