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

Model Number	NS7TCFL174HS
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Heart Block (4444)
Date of Event	11/26/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information received indicates that the device is not available for return, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device 30428420m number, and no internal action related to the complaint was found during the review.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.(b)(6).Manufacturer's ref.# (b)(4).
Event or Problem Description
It was reported that a patient underwent cardiac ablation procedure for atrioventricular nodal reentrant tachycardia (avnrt) with navistar¿ electrophysiology catheter and suffered heart block requiring temporary pacemaker implantation.First ablation (60 sec) of the slow pathway with partial success.After re-induction, a second ablation was attempted.Forty (40) seconds into the ablation a steam pop occurred.And the patient developed an atrioventricular (av) block.A temporary pacemaker was implanted.There was no temperature rise (below 50 degrees always) and no impedance rise neither.Between normal parameters.Smartablate rf generator was used with temperature control mode.The event occurred during use of biosense webster products.The physician¿s causality opinion was not provided.The outcome is unknown.There was no information whether the patient's condition required extended hospitalization.Since pacemaker was required the event is coded as complete heart block.

• Brand Name: NAVISTAR ELECTROPHYSIOLOGY CATHETER
• Common Device Name: CATHETER, ELECTRODE RECORDING
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 33 technology drive; irvine CA 92618
• MDR Report Key: 11055808
• Report Number: 2029046-2020-01974
• Device Sequence Number: 4241955
• Product Code: DRF
• UDI-Device Identifier: 10846835000610
• UDI-Public: 10846835000610
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: P990025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/26/2020

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: 08/31/2023
• Device Model Number: NS7TCFL174HS
• Device Catalogue Number: NS7TCFL174HS
• Device Lot Number: 30428420M
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2020
• Initial Report FDA Received Date: 12/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK_SMARTABLATE GENERATOR
• Outcome Attributed to Adverse Event: Required Intervention