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

Model Number	NS7TCDL174HS
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Heart Block (4444)
Date of Event	04/14/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent a paroxysmal supraventricular tachycardia ablation procedure with a navistar¿ electrophysiology catheter.The patient suffered a heart block.It was reported that atrioventricular block (avb)occurred during atrioventricular nodal re-entrant tachycardia (avnrt) treatment.Timing was when ablation was conducted.Heart rate hr70 was present at the junctional rhythm, and the procedure was terminated with follow-up.The physician's judgment on health hazard of heart block is non-serious (moderate/minor).There was no abnormality before and during use of the product.
Additional Manufacturer Narrative
E1.Initial reporter facility name (cont.): (b)(6) hospital.E 1.Initial reporter phone: (b)(6).If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster, inc., or its employees that the report constitutes an admission that the product, biosense webster, inc., or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.Section h3.Has been updated.A manufacturing record evaluation (mre) was performed for the finished device and no internal action related to the complaint was found during the review.Additionally, the manufactured date has been provided.Therefore, field h4.Device manufacture date has been populated.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

• Brand Name: NAVISTAR¿ ELECTROPHYSIOLOGY CATHETER
• Common Device Name: CATHETER, ELECTRODE RECORDING
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 16920503
• Report Number: 2029046-2023-01017
• Device Sequence Number: 6930327
• Product Code: DRF
• UDI-Device Identifier: 10846835000597
• UDI-Public: 10846835000597
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2023

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: 09/07/2025
• Device Model Number: NS7TCDL174HS
• Device Catalogue Number: NS7TCDL174HS
• Device Lot Number: 30901513M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2023
• Supplement Date Received by Manufacturer: 05/25/2023
• Initial Report FDA Received Date: 05/12/2023
• Supplement Report FDA Received Date: 06/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/08/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SMARTABLATE GEN. KIT (JAPAN).
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown