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); Display or Visual Feedback Problem (1184); Contamination /Decontamination Problem (2895); Sharp Edges (4013)

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

Event Date 06/16/2021

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) procedure with a pentaray nav high-density mapping eco catheter and a biosense webster, inc.Product analysis lab observed ¿electrode damage¿ and ¿foreign particles in electrodes¿.Initially it was reported that there was no visualization of one spline of the catheter.Also, there was noise on the catheter.In visualization, no spline or dark black electrode number 13-14 and 15-16.The cable was changed but problem remained the same.The catheter needed to be changed and the problem solved.No patient consequence was reported.The visualization issue was assessed as not mdr reportable.The device is not visualized by the carto system.The user will have to replace the catheter in order to complete the case.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 noise issue was assessed as not mdr reportable.The risk to the patient was low.The biosense webster, inc.Product analysis lab received the device for evaluation and per the evaluation completion on 16-dec-2021 there was damages on several rings and foreign material found under some electrodes in the spline d.The returned condition was assessed as mdr reportable for both ¿electrode damage¿ and ¿foreign particles in electrodes¿.The awareness date for these reportable lab findings was 16-dec-2021.

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on 02-nov-2021.The device evaluation was completed on 16-dec-2021.The product was returned to biosense webster for evaluation.Bwi conducted a visual inspection, electrical and fourier transform infrared spectroscopy (ftir) evaluation of the returned device.Visual analysis of the returned sample revealed damages on several rings and foreign material found under some electrodes in the spline d of the pentaray nav eco device.An electrical test was performed, and the device failed; no electrical readings were observed on the damaged electrodes, 13,14, and 15.The failure during the testing could be related to the damage found in the electrodes causing that the electrical wire was found broken, provoking the improper electrical signal.The foreign material found was analyzed and revealed that it is primarily composed of acrylonitrile butadiene styrene - base material (abs).However, the source of origin remains unknown.As part of bwi's quality process, all devices are manufactured, inspected, and released to approved specifications.To avoid physical damages to spline, the following guidelines should be followed.Do not introduce the pentaray¿ naveco catheter into a guiding sheath with its distal splines folded backwards (i.E., toward the handle).Collapse the splines together using the insertion tube prior to insertion; and this catheter is recommended for use with an 8 f guiding sheath as the distal splines may be damaged if used with a sheath that is not compatible 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.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

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4) during an internal review on (b)(6)2022, noted a correction to the 3500a as h10.Additional manufacturer narrative as it should have included, ¿a manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.¿.

• 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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 13201749
• MDR Text Key: 288364841
• Report Number: 2029046-2022-00047
• Device Sequence Number: 1
• Product Code: MTD
• UDI-Device Identifier: 10846835012255
• UDI-Public: 10846835012255
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K123837
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/10/2022

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 Expiration Date: 01/11/2024
• Device Model Number: D128211
• Device Catalogue Number: D128211
• Device Lot Number: 30502640L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/09/2022
• Initial Date FDA Received: 01/09/2022
• Supplement Dates Manufacturer Received: 01/09/2022
• Supplement Dates FDA Received: 01/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/12/2021
• 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: UNKNOWN BRAND CABLE; UNKNOWN BRAND CABLE; UNKNOWN BRAND CATHETER