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

Catalog Number R7D282CT

Device Problems Material Deformation (2976); Material Protrusion/Extrusion (2979)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/28/2024

Event Type  malfunction  

Event Description

It was reported that a patient underwent a supraventricular tachycardia ablation procedure with a decanav electrophysiology catheter and before the operation, the electrodes on the tip of the device were found detached (no exposed wires) when the package was just opened.There were exposed braids.There were no lifted or sharpened electrodes.A second device was used to complete the operation.There was no adverse event reported on patient.The damaged device was not used in patient.

Manufacturer Narrative

Note: e1 initial reporter facility name: (b)(6) hospital.The product has not returned for analysis, however, a picture(s) were provided by the customer.Evaluation is still in progress.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.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).

Manufacturer Narrative

On (b)(6) 2024, the bwi product analysis lab received the device for evaluation.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

On 30-apr-2024, the product investigation was completed.It was reported that a patient underwent a supraventricular tachycardia ablation procedure with a decanav electrophysiology catheter and before the operation, the electrodes on the tip of the device were found detached (no exposed wires) when the package was just opened.There were exposed braids.There were no lifted or sharpened electrodes.A second device was used to complete the operation.There was no adverse event reported on patient.The damaged device was not used in patient.Device evaluation details: visual analysis revealed that the electrodes #2 and #3 were detached from the rest of the device, they were not returned for evaluation with the rest of the device.For the observed condition, a manufacturing investigation was requested, and it was concluded that the damage is not related to the manufacturing process since the process instructions specified the correct assembly method regarding to weld rings, polyurethane (pu) rings, and its corresponding inspection controls as resistance and electrical test, workmanship, and final quality inspection as well the final packaging inspection.A manufacturing record evaluation was performed for the finished device number lot 31165886m and no internal action related to the complaint was found during the review.The electrodes detachment issue was confirmed based on the findings during the analysis of the device.The potential cause of the electrode detachment cannot be determined, it could be related to the handling of the device before the operation however, this cannot be conclusively determined.The instruction for use states: prior to removal of the catheter, confirm that the thumb knob has been pulled back completely (straightened).Remove the catheter and dispose of it in an appropriate manner.As part of biosense webster's quality process, all devices are manufactured, inspected, and released to approved specifications.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: 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: 18969945
• MDR Text Key: 339210046
• Report Number: 2029046-2024-01007
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 10846835008791
• UDI-Public: 10846835008791
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K080425
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: R7D282CT
• Device Lot Number: 31165886M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/28/2024
• Initial Date FDA Received: 03/25/2024
• Supplement Dates Manufacturer Received: 04/03/2024; 10/06/2015
• Supplement Dates FDA Received: 04/25/2024; 05/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/19/2023
• 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