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

Catalog Number R7D282CT

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Heart Block (4444)

Event Date 01/10/2024

Event Type  Injury  

Manufacturer Narrative

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 lot 31175663m 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 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).

Event Description

It was reported that a patient underwent an atrial fibrillation ablation with a decanav electrophysiology catheter and the patient experienced heart block that required temporary pacemaker insertion.The heart block was discovered while going up with the sl1 sheath when the patient stopped having atrioventricular (av) conduction.The anestheologist stated that the patient's blood pressure started to drop.The soundstar catheter confirmed there was no effusion.The decanav catheter was used to pace the ventricle.The heart block was observed on the recording system.Electrograms confirmed the heart block.The medical intervention provided was watching the patient for 20 or 30 minutes.The av block went away, and the patient was still bradycardic.The physician wanted to do further electrophysiology (ep) study on the patient.The physician was testing a temporary pacemaker in the patient.The physician believes that the heart block could have been a symptom of the patient¿s existing sinus node dysfunction.The patient was reported to be in stable condition and will be observed overnight to evaluate if the patient needs a permanent pacemaker.An ablation catheter was not used during the procedure.No ablation was done during the procedure.The biosense webster cs catheter was in the heart but the patient went into heart block when they were going up with the sl1 sheath.After conduction came back, they looked at the patient¿s previous electrocardiogram (ekgs) and it was evident they were having heart block before.Intervention included right ventricular (rv) pacing until conduction came back.A temporary pacemaker was placed to monitor the patient overnight.Patient has fully recovered.No extended hospitalization was required.

• 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: 18628811
• MDR Text Key: 334368683
• Report Number: 2029046-2024-00379
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 10846835008791
• UDI-Public: 10846835008791
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080425
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/01/2024

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: R7D282CT
• Device Lot Number: 31175663M
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/10/2024
• Initial Date FDA Received: 02/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/25/2023
• 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: BIOSENSE CS CATHETER; NGEN RF GENERATOR, US; UNK SL1 SHEATH; UNK_SOUNDSTAR
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Sex: Male