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

Model Number D128211

Device Problem Material Separation (1562)

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

Event Date 11/15/2022

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone: (b)(6).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.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).

Event Description

It was reported that an unknown patient underwent an unknown ablation procedure with a pentaray nav high-density mapping eco catheter and a broken catheter shaft issue occurred.During left atrium (la) pre-mapping, the base of the spine was broken as a sensation during catheter operation.The pentaray was replaced, and the issue was resolved.The procedure was completed without patient consequence.This was assessed as a mdr reportable product malfunction.

Manufacturer Narrative

Additional information was received on 22-dec-2022.It was reported that the damage did not result in wires/internal components being exposed, nor in any lifted or sharp rings.There was no resistance or difficulty during insertion or removal of the catheter.It was unknown how far the issue was found from the distal end of the catheter.There is no picture available.A nihon kohden.8.5fr sl0 sheath (non-biosense webster) was used.Therefore, the concomitant product section was updated.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 device evaluation was completed on 02-feb-2023.It was reported that a patient underwent an unknown ablation procedure with a pentaray nav high-density mapping eco catheter and a broken catheter shaft issue occurred.During left atrium (la) pre-mapping, the base of the spine was broken as a sensation during catheter operation.The pentaray was replaced, and the issue was resolved.The procedure was completed without patient consequence.Device evaluation details: the device was returned to biosense webster (bwi) for evaluation.A visual inspection and magnetic sensor functionality test of the returned device were performed following bwi procedures.Visual analysis revealed no damage or anomalies on the device.The splines were seen in good condition as well as the spine, shaft, and handle.A manufacturing record evaluation was performed for the finished device 30867471l number, and no internal action related to the complaint was found during the review.The issue reported by the customer could not be confirmed 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 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: 15983452
• MDR Text Key: 308145765
• Report Number: 2029046-2022-03122
• Device Sequence Number: 1
• Product Code: MTD
• UDI-Device Identifier: 10846835012255
• UDI-Public: 10846835012255
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K123837
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/02/2023

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 Model Number: D128211
• Device Catalogue Number: D128211
• Device Lot Number: 30867471L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/15/2022
• Initial Date FDA Received: 12/14/2022
• Supplement Dates Manufacturer Received: 12/22/2022; 02/02/2023
• Supplement Dates FDA Received: 01/18/2023; 03/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/16/2022
• 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: NON-BWI NIHON KOHDEN. 8.5FR SL0 SHEATH.; UNK BRAND CATHETER.