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

Catalog Number R7F282CT

Device Problems Break (1069); Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 08/15/2023

Event Type  malfunction  

Manufacturer Narrative

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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a decanav electrophysiology catheter and a portion of the covering for the catheter shaft was missing exposing internal components.It was reported by the caller that the decanav electrophysiology catheter had physical damage when removed from the sterile packaging, the device secured properly in the tray.The caller noted that they noticed the distal end (approximately 1 inch proximal to the electrodes), had a defect in the catheter.The caller noted that they could see exposed wiring and a portion of the covering for the catheter shaft was missing.The catheter was exchanged and the issue was resolved.The case continued.There was no patient consequence.

Manufacturer Narrative

On 18-sep-2023, the bwi product analysis lab received the complaint device for evaluation.The product 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 ref.# (b)(4).

Manufacturer Narrative

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a decanav electrophysiology catheter and a portion of the covering for the catheter shaft was missing exposing internal components.It was reported by the caller that the decanav electrophysiology catheter had physical damage when removed from the sterile packaging, the device secured properly in the tray.The caller noted that they noticed the distal end (approximately 1 inch proximal to the electrodes), had a defect in the catheter.The caller noted that they could see exposed wiring and a portion of the covering for the catheter shaft was missing.The catheter was exchanged and the issue was resolved.The case continued.There was no patient consequence.Device evaluation details: the device was returned to biosense webster (bwi) for evaluation.Visual inspection of the returned device were performed following bwi procedures.Visual analysis revealed no damage or anomalies on the device.The tip was observed without problems, no exposed wiring were observed missing.No portion of the covering for the catheter shaft were missing.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The issue reported by the customer could not be replicated during the product investigation; other issues or circumstances may have occurred during the usage of the device that compromised its performance.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 ref.# (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: 17732813
• MDR Text Key: 323318244
• Report Number: 2029046-2023-02053
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 10846835008807
• UDI-Public: 10846835008807
• 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,Followup,Followup
• Report Date: 10/19/2023

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: 31077007M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/15/2023
• Initial Date FDA Received: 09/12/2023
• Supplement Dates Manufacturer Received: 09/18/2023; 10/10/2023
• Supplement Dates FDA Received: 09/19/2023; 10/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/16/2023
• 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: CARTO 3 SYSTEM