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

Model Number D128211

Device Problems Signal Artifact/Noise (1036); Material Deformation (2976); Sharp Edges (4013)

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

Event Date 02/24/2022

Event Type  malfunction  

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on 16-mar-2022.The device evaluation was completed on 20-apr-2022.The product was returned to biosense webster for evaluation.Bwi conducted a visual inspection, functional, and electrical evaluation of the returned device.Visual analysis of the returned sample revealed damages on the 3rd spline of the pentaray nav eco device.Electrode #12 was observed lifted without pu on the edge an electrical test was performed, and the device failed; no electrical readings were observed on electrodes, 11 and 12.Product analysis was performed, and the wire from electrodes 11 and 12 were found broken, near the tip, causing the improper electrical signal.The magnetic sensor functionality test was performed, per bwi procedures.No magnetic sensor issues were observed.During the magnetic sensor functionality test, the device was displayed correctly.As part of bwi¿s quality process, all catheters are manufactured, inspected, and released to approved specifications.To minimize ecg noise, the following guidelines should be followed.Ecg noise is typically generated as the result of the improper connection of the body surface ecg patch to the patient.This noise is the most significant during ablation.To resolve this situation, verify the proper connection.It is recommended to turn off the notch filter for this verification.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent a paroxysmal atrial fibrillation (afib) procedure with a pentaray nav high-density mapping eco catheter and the biosense webster, inc.Product analysis lab observed an electrode lifted without polyurethane (pu) on the edge.Initially it was reported that after inserting the new pentaray nav high-density mapping eco catheter into the body, there were no signals for electrodes 9, 10 on the carto 3 system and recording system.The pentaray nav high-density mapping eco catheter connections were re-seated without resolution.The pentaray nav high-density mapping eco catheter was removed from the body and it was noticed that the electrode on the catheter looked "bent." they believe the cause of the issue is due to the bent electrode on the pentaray nav high-density mapping eco catheter.The procedure continued with the issue persisting and they hid electrode signals 9, 10.There was no patient consequence reported.Additional information was received on the event.Damage did not result in wires and/or being exposed.The damage did not result in any lifted or sharp rings.One pentaray nav high-density mapping eco catheter (believe lot # 30720349l) there was resistance noted while pulling on the plunger of the handle to manipulate.No attempt made to insert in the patient¿s body due to difficulty with manipulation beforehand.Unsure of which brand sheath was used.The signal issue was assessed as not mdr reportable for a ¿bad/ partial ecg (bs or ic)¿ issue.The risk to the patient was low.The electrode issue was assessed as not mdr reportable for an ¿electrode damaged without foreign material- without sharp/rough edges¿ issue.Electrode rings are smooth or dull.The most likely consequence was an intraprocedural delay.The potential risk that it could cause or contribute to a serious injury or death was remote.The biosense webster, inc.Product analysis lab received the device for evaluation and per the evaluation completion on 20-apr-2022 revealed damages on the 3rd spline of the pentaray nav high-density mapping eco catheter.Electrode #12 was observed lifted without pu on the edge.The electrode lifted without pu on the edge was assessed as mdr reportable.The awareness date for this reportable lab finding was 20-apr-2022.

• 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 ; MX
• Manufacturer Contact: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 14349958
• MDR Text Key: 291945970
• Report Number: 2029046-2022-00997
• Device Sequence Number: 1
• Product Code: MTD
• UDI-Device Identifier: 10846835012255
• UDI-Public: 10846835012255
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123837
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/10/2022

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 Model Number: D128211
• Device Catalogue Number: D128211
• Device Lot Number: 30720349L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2022
• Initial Date Manufacturer Received: 04/20/2022
• Initial Date FDA Received: 05/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/19/2022
• 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: PENTARAY NAV ECO 7FR, D, 2-6-2; UNKNOWN BRAND RECORDING SYSTEM; UNKNOWN BRAND SHEATH; UNK_CARTO 3