MAUDE Adverse Event Report: BIOSENSE WEBSTER INC HALO¿ XP ELECTROPHYSIOLOGY CATHETER WITH AUTO ID; CATHETER, ELECTRODE RECORDING OR PROBE, ELECTRODE RECORDING

Model Number	D7T20282CT
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	07/26/2022
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 number 30782262l 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.Manufacturer's ref.# (b)(4).
Event or Problem Description
It was reported that a 66-year-old male patient underwent a afib ¿ paroxysmal ablation procedure with a halo¿ xp electrophysiology catheter with auto id and the patient suffered a cardiac arrest requiring cardiopulmonary resuscitation (cpr).It was reported that while performing a cavotricuspid ishmus (cti) line, the halo¿ xp electrophysiology catheter with auto id potentially flipped into the right ventricle temporarily causing the right ventricle (rv) pacemaker lead to dislodge.The patient is pacemaker dependent and lost pacing from the lead.Cpr was performed briefly, and the pacemaker lead started pacing again on its own.The bwi representative described it as a micro-dislodgement and stated that no further intervention was planned at that time.The physician believes that the adverse event was a cause of a combination of a procedural event and patient condition.The patient¿s condition improved; they were extubated and discharged the following morning with no lead revision needed.The patient did require extended hospitalization.They were admitted and spent one night in the intensive care unit (icu).Patient had normal electrolyte levels.Additional information received indicated the halo¿ xp electrophysiology catheter with auto id was positioned in the right atrium along with the octaray catheter.The physician was manipulating the octaray catheter while actively mapping the chamber.The physician stated after the event occurred that they thought the halo catheter had flipped through the tricuspid valve and into the right ventricle, got wrapped around the pacemaker lead, and caused what they were calling a micro-dislodgement; the lead was not permanently removed, just was affected enough to not capture surrounding tissue for a brief period.

• Brand Name: HALO¿ XP ELECTROPHYSIOLOGY CATHETER WITH AUTO ID
• 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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-7981
• MDR Report Key: 15272487
• Report Number: 2029046-2022-01949
• Device Sequence Number: 20303499
• Product Code: DRF
• UDI-Device Identifier: 10846835005981
• UDI-Public: 10846835005981
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K953663
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/22/2022

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: 04/17/2025
• Device Model Number: D7T20282CT
• Device Catalogue Number: D7T20282CT
• Device Lot Number: 30782262L
• 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: 07/26/2022
• Initial Report FDA Received Date: 08/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2022
• 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: UNK_OCTARAY NAV
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization; Life Threatening
• Patient Age: 66 YR
• Patient Sex: Male