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

Catalog Number R7F282CT

Device Problems Manufacturing, Packaging or Shipping Problem (2975); Material Protrusion/Extrusion (2979)

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

Event Date 01/01/2023

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) - persistent ablation procedure which included a decanav electrophysiology catheter.During persistent afib ablation, before introduction, the decanav catheter insulation was not properly sealed.The catheter wires were visible.The catheter was physically damaged and cannot be introduced into the patient.

Manufacturer Narrative

B3.Date of event: the event date is unknown.As a result, the 1st day of the year has been entered as the event date.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.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

Initially, it was reported that the decanav catheter insulation was not properly sealed.The catheter wires were visible.The biosense webster, inc.Product analysis lab received the device and observed on 16-nov-2023 that the tip of the device was partially detached.This additional finding was also assessed as mdr reportable with an awareness date of 16-nov-2023.Device evaluation details: the device evaluation was completed on 16-nov-2023.The device was returned to biosense webster (bwi) for evaluation.A visual inspection evaluation of the returned device was performed following bwi procedures.Visual analysis of the returned sample revealed that the tip of the device was partially detached; however, during the analysis, adhesive residues were observed concluding in a good manufacturing assembly process.A manufacturing record evaluation (mre) was performed for the finished device 31114078m number, and no internal action related to the complaint was found during the review.Based on the completed mre, the manufactured date and expiration date have been provided.Therefore, fields d4.Expiration date and h4.Device manufacture date have been populated with appropriate information.The issue reported was confirmed.The root cause of this failure could be related to the excessive force or manipulation of the device during the handling.It should be noted that product failure is multifactorial.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.This product issue will be addressed through bwi¿s quality system.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

The biosense webster, inc.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).

• 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: 17900490
• MDR Text Key: 325724869
• Report Number: 2029046-2023-02263
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 10846835008807
• UDI-Public: 10846835008807
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 12/14/2023

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: R7F282CT
• Device Lot Number: 31114078M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/13/2023
• Initial Date FDA Received: 10/09/2023
• Supplement Dates Manufacturer Received: 10/26/2023; 11/16/2023
• Supplement Dates FDA Received: 11/08/2023; 12/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/03/2023
• 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