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

Model Number	F6QA005CT
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Heart Block (4444)
Date of Event	10/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device investigation details: the device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device (b)(4) number, and no internal action related to the complaint was found during the review.This report is being submitted pursuant to the provisions of 21 cfr, part 4.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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Biosense webster manufacturer's reference number (b)(4)has four (4) reports: (1) mfr # 2029046-2021-01958 for product code (b)(4) (webster¿ electrophysiology catheter) (2) mfr # 2029046-2021-01959 for product code (b)(4) (webster¿ electrophysiology catheter) (3) mfr # 2029046-2021-01960 for product code (b)(4) (webster®cs catheter with ez steer® technology and auto id) (4) mfr # 2029046-2021-01961 for product code (b)(4) (webster®cs catheter with ez steer® technology and auto id) ll.
Event or Problem Description
It was reported that a patient underwent an electrophysiology (ep) study with two (2) webster¿ electrophysiology catheter & two (2) webster ® cs catheter with ez steer® technology and auto id and the patient experienced atrioventricular (av) heart block requiring permanent pacemaker implantation.During an ep study, the patient presented av block of 1 minute.Back-up pacing with a catheter placed in the right ventricle (rv) was possible.After a waiting period under pacing, the physician tested if the av conduction was back, but it was not completely.So continuous pacing from the rv catheter was necessary.The patient underwent then a coronarography and a pacing sonde (temporary pacemaker) was implanted to ensure back-up pacing in case of av block.There is no further information about if prolonged hospitalization was required.The physician opinion is that it is not a complication due to the procedure, but a pre-existing patient-related problem.No ablation or ablation catheter was in use at any time.Based on the information initially provided, this event was assessed as not mdr reportable based on physician¿s opinion indicating this was a patient related pre-existing condition.On (b)(6) 2021, biosense webster inc.(bwi) received additional information indicating the adverse event was discovered during use of biosense webster products.Physician¿s opinion on the cause of this adverse event is that it was patient condition related.The patient¿s outcome from the adverse event was reported as unchanged and the patient required implantation of a permanent cardiac resynchronization therapy (crt) pacemaker.Based on the additional information which indicated the patient required permanent pacemaker implantation, this event will be conservatively reported as an adverse event (serious injury) against the bwi devices used during the ep study.

• Brand Name: WEBSTER¿ ELECTROPHYSIOLOGY CATHETER
• Common Device Name: CATHETER, ELECTRODE RECORDING, OR PROBE, 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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 12806522
• Report Number: 2029046-2021-01958
• Device Sequence Number: 20022941
• Product Code: DRF
• UDI-Device Identifier: 10846835007886
• UDI-Public: 10846835007886
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K892265
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/12/2021

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: 07/27/2024
• Device Model Number: F6QA005CT
• Device Catalogue Number: F6QA005CT
• Device Lot Number: 30614205M
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2021
• Initial Report FDA Received Date: 11/12/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2021
• 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: BI DIR 7FR DEF CS,D-F,12 PIN.; BI DIR 7FR DEF CS,D-F,12 PIN.; FIX 6F,4P,A,SD,5MM,12PN EEPROM.; SMARTABLATE GENERATOR KIT-WW.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown