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

Catalog Number SEE H10

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Cardiac Arrest (1762)

Event Date 12/20/2023

Event Type  Injury  

Manufacturer Narrative

H4.Catalog: unk_c3 cs refstar-deflectable.The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturing record evaluation (mre) cannot be conducted because no lot number was provided by the customer.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.Biosense webster manufacturer's reference number (b)(4) has two reports: (1) mfr # 2029046-2024-00217 for product code unk_c3 cs refstar-deflectable (decanav electrophysiology catheter) , (2) mfr # 2029046-2024-00216 for product code r7f282ct (decanav electrophysiology catheter).

Event Description

It was reported that a patient underwent an atrial fibrillation ablation procedure with a decanav electrophysiology catheter (unk_c3 cs refstar ¿ deflectable) and a decanav electrophysiology catheter (d-1285-02-s) and the patient experienced a cardiac arrest that required cardiopulmonary resuscitation (cpr) /defibrillation.First, it was reported that a catheter sensor error 105 displayed on the carto 3 system.The cable was replaced without resolution.After a replacement catheter was opened, the patient¿s blood pressure dropped and the ecg displayed pulseless electrical activity (pea).Cpr was performed until the patient presented with a rhythm and pulse.The case was aborted.The patient was taken to computed tomography (ct) then to the intensive care unit (icu) for observation.No ablation radio frequency (rf) was applied.The ablation catheter (thmcl smtch sf bid, tc, d-f) was opened but not used.Additional information was received.Intervention included cpr, defibrillation and transesophageal echocardiogram (tee).Patient has improved.Physician did not have an opinion about the cause and was not sure what the root could be.The devices inside the patient at the time of the event was the vizigo sheath, sterilmed catheter (soundstar eco 8f diagnostic ultrasound catheter), decanav electrophysiology catheter (unk_c3 cs refstar ¿ deflectable) and the decanav electrophysiology catheter (d-1285-02-s in the esophagus).No transseptal had been performed.They suspect it was anesthesia related.The mapping catheter (thmcl smtch sf bid, tc, d-f) had a 105 error but was never inserted into the body.No other bwi product issues occurred.There was no sensor error with the reprocess sdstr eco 8f-90 sms (sterilmed), it was on the ablation catheter.The reprocess sdstr eco 8f-90 sms performed as expected.The reprocess sdstr eco 8f-90 sms and the vizigo sheath will be returned for analysis only.The catheter sensor error 105 was assessed as non mdr reportable.The incidence of magnetic sensor error was easy detectable by the user.The catheter was inoperable, since it cannot be visualized on the carto system.The user will have to replace the catheter.The most likely consequence was an intraprocedural delay.The potential risk that it could cause or contribute to a serious injury or death was remote.The adverse event was assessed mdr reportable under the two mapping catheters decanav electrophysiology catheter (unk_c3 cs refstar ¿ deflectable) and the decanav electrophysiology catheter (d-1285-02-s).

• Brand Name: DECANAV ELECTROPHYSIOLOGY CATHETER
• Type of Device: 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 18539701
• MDR Text Key: 333194937
• Report Number: 2029046-2024-00217
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 10846835008791
• UDI-Public: 10846835008791
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/18/2024

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 Catalogue Number: SEE H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/20/2023
• Initial Date FDA Received: 01/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: 7FR DECAN,11P,F,2.4MMLE,282MM,; 8.5F SHEATH WITH CURVE VIZ MDC; CBL, 34 HYP/34 LEMO, 10'; REPROCESS SDSTR ECO 8F-90 SMS; THMCL SMTCH SF BID, TC, D-F; UNK_CARTO 3; UNK_SMARTABLATE GENERATOR
• Patient Outcome(s): Life Threatening; Required Intervention; Hospitalization
• Patient Sex: Male