MAUDE Adverse Event Report: BIOSENSE WEBSTER INC PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER; CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY

Catalog Number D128211

Device Problems Signal Artifact/Noise (1036); Device-Device Incompatibility (2919); Material Twisted/Bent (2981)

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

Event Date 10/19/2023

Event Type  malfunction  

Event Description

It was reported that a patient underwent a cardiac ablation procedure which included the use of pentaray nav high-density mapping eco catheter for which biosense webster¿s product analysis lab (pal) identified a few electrodes that were lifted causing internal parts exposed and the splines were slightly bent.Initially, it was reported that there was difficulty inserting the pentaray into the sheath.There were ¿big noises¿ on the signals of branch 7-8 and 9-10.After removing the catheter from the patient, the branch seemed to be ¿drawn¿.It was noted that the branch of the pentaray is physically damaged.Another device was used to continue the procedure.There was no patient consequence.The resistance with sheath, signal noise, and tip/spline bent were assessed as non mdr reportable.The potential risk that it could cause or contribute to a serious injury or death to the operator or patient was remote.The biosense webster, inc.Product analysis lab received the device for evaluation and per the evaluation completion on 15-feb-2024, a few electrodes of the device were observed lifted causing internal parts exposed and the splines were slightly bent.The damaged electrode was assessed as mdr reportable.The awareness date for this reportable lab finding was 15-feb-2024.

Manufacturer Narrative

The device was returned to biosense webster (bwi) for evaluation.A visual inspection and functional tests of the returned device were performed following bwi procedures.Visual analysis revealed that a few electrodes of the device were observed lifted causing internal parts exposed and the splines were slightly bent.A dimensional test was performed, and outer diameters of the device were found within specifications.An electrical test was performed, and open circuit was found on the tip area and is related to the damage on the electrodes.The root cause of the failure in the electrodes could be related to the excessive force or manipulation of the device during the procedure; however, this cannot be conclusively determined.A manufacturing record evaluation was performed for the finished device 30973622l number, and no internal actions related to the reported complaint condition were identified.The issues reported by the customer were confirmed.It should be noted that product failure is multifactorial.The instructions for use contain (ifu) the following recommendations: do not use excessive force to advance or withdraw the catheter through the guiding sheath when resistance is encountered.As part of the quality process, all devices are manufactured, inspected, and released to approved specifications.Explanation of codes: investigation findings: open circuit (c0205) / investigation conclusions: cause not established (d15) / component code: electrical lead/wire (g02015) were selected as related to the internal parts (wires) exposed.Investigation findings: stress problem identified (c0706) / investigation conclusions: cause not established (d15) / component code: electrode (g0201501) were selected as related to the damaged electrode.Investigation findings: mechanical problem identified (c07) / investigation conclusions: cause not established (d15) / component code: tip (g04129) were selected as related to the splines that were slightly bent.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).

• Brand Name: PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER
• Type of Device: CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY
• 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: 18877561
• MDR Text Key: 337363767
• Report Number: 2029046-2024-00792
• Device Sequence Number: 1
• Product Code: MTD
• UDI-Device Identifier: 10846835012255
• UDI-Public: 10846835012255
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K123837
• 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
• Report Date: 03/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: D128211
• Device Lot Number: 30973622L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2024
• Date Manufacturer Received: 02/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/13/2022
• 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: BRK AND SL0 NEEDLE; UNK BRAND SHEATH; UNK_C3 WEBSTER DECAPOLAR WITH AUTO ID - FIXED; UNK_SMART TOUCH BIDIRECTIONAL SF