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); Material Twisted/Bent (2981)

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

Event Date 11/06/2023

Event Type  malfunction  

Manufacturer Narrative

The device evaluation was completed on 02-jan-2024.The device was returned to biosense webster (bwi) for evaluation.Visual inspection and electrical test of the returned device were performed following bwi procedures.Visual analysis revealed one of the splines of the device was squashed: the electrode was lifted and an internal wire was exposed.All units are inspected prior to leaving the facility to avoid this type of damage.With the available information, it can be concluded that the issue occurred outside the manufacturing environment.Also, an electrical test was performed, and no electrical issues were found.A manufacturing record evaluation was performed for the finished device number, and no internal actions related to the reported complaint were identified.The electrical 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.The instructions for use contain the following recommendation: 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.On the other hand, the issue regarding the twisted condition of the device was confirmed, based on the condition observed.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.Explanation of codes: -investigation findings: no device problem found (c19)/ investigation conclusions: no problem detected (d14) were selected as related to the customer¿s reported, ¿strong noises on the signal of the electrode 11-12¿.-investigation findings: stress problem identified (c0706) / investigation conclusions: cause not established (d15) / component code: electrode (g0201501) were selected as related to the customer¿s reported ¿spline seems twisted¿ and the biosense webster inc.Analysis finding of the ¿splines of the device was squashed: the electrode was lifted and an internal wire was exposed¿.Manufacturer¿s reference number: (b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) procedure with a pentaray nav high-density mapping eco catheter for which biosense webster¿s product analysis lab (pal) identified an electrode lifted and an internal wire exposed.Initially it was reported strong noises on the signal of the electrode 11-12.At the inspection, one of the spline seems twisted.Cable and catheter replacement.No delay.No patient consequence.The biosense webster, inc.Product analysis lab received the device for evaluation and per the evaluation completion on 02-jan-2024, observed one of the splines of the device was squashed: the electrode was lifted and an internal wire was exposed.This event was originally considered non-reportable, however, bwi became aware of the electrode was lifted and an internal wire was exposed on 02-jan-2024 and have assessed this returned condition as reportable.

• 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: 18567798
• MDR Text Key: 333541049
• Report Number: 2029046-2024-00275
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2024
• 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: 31088278L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2023
• Date Manufacturer Received: 01/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/13/2023
• 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: UNK CABLE