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); Break (1069); Display or Visual Feedback Problem (1184); Device-Device Incompatibility (2919)

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

Event Date 08/04/2023

Event Type  malfunction  

Event Description

It was reported that a patient underwent a cardiac ablation procedure with a pentaray nav high-density mapping eco catheter which resulted with a damaged catheter tip.It was reported there was a little resistance when inserting the pentaray nav high-density mapping eco catheter into the carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium.After the catheter was placed in the left atrium, it was noticed that only 4 splines were displayed.Matrix was completely built up but on the recording system, no signals could be seen on the splines, they were not visible.When the catheter was pulled out, the pentaray nav high-density mapping eco catheter was clearly damaged.There was no patient consequences.The customer¿s reported issues of visualization, noise and resistance with the sheath are not considered to be mdr reportable since the potential risk that these could cause or contribute to a serious injury or death is remote.

Manufacturer Narrative

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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Biosense webster manufacturer's reference number (b)(4) has two reports: for product code d128211 (pentaray nav high-density mapping eco catheter).(2) mfr # 2029046-2023-01999 for product code d138502 (carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium).

Manufacturer Narrative

On 16-oct-2023, the bwi product analysis lab received the complaint device for evaluation.The product analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Manufacturer Narrative

It was reported that a patient underwent a cardiac ablation procedure with a pentaray nav high-density mapping eco catheter which resulted with a damaged catheter tip.It was reported there was a little resistance when inserting the pentaray nav high-density mapping eco catheter into the carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium.After the catheter was placed in the left atrium, it was noticed that only 4 splines were displayed.Matrix was completely built up but on the recording system, no signals could be seen on the splines, they were not visible.When the catheter was pulled out, the pentaray nav high-density mapping eco catheter was clearly damaged.There was no patient consequences.The customer¿s reported issues of visualization, noise and resistance with the sheath are not considered to be mdr reportable since the potential risk that these could cause or contribute to a serious injury or death is remote.Device evaluation details: the device was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.A visual inspection, magnetic sensor functionality, electrical and dimensional test of the returned device were following bwi procedures.Visual analysis revealed no broken condition in the tip; however, one of the splines was bent and an electrode was lifted with wires exposed.A dimensional test was performed, and the results were found within specifications.Afterward, a magnetic sensor functionality test was performed and the device was recognized on the system; however, error 337 was displayed on the screen.An electrical test was also performed and the results were found out of specifications.Magnetic and electrical failures are related to open circuits in the tip area.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.Since a bent spline and dented electrode were observed, all the issues reported by the customer were confirmed.The root cause of the failure in the electrode and spline could be related to the excessive force or manipulation of the device during the procedure; however, this cannot be conclusively determined.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 biosense webster's quality process, all devices are manufactured, inspected, and released to approved specifications.Explanation of codes: investigation findings: mechanical problem identified (c07) / investigation conclusions: cause not established (d15) / component code: tip (g04129) were selected as related to the bent spline.Investigation findings: stress problem identified (c0706) / investigation conclusions: cause not established (d15) / component code: electrode (g0201501)were selected as related to the lifted electrode and resistance with thee sheath.Investigation findings: open circuit (c0205) / investigation conclusions: cause not established (d15) / component code: sensor (g03012) were selected as related to the customer¿s reported visualization issues.Investigation findings: open circuit (c0205) / investigation conclusions: cause not established (d15) / component code: electrical lead/wire (g02015) were selected as related to the customer¿s reported signal noise issues.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (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: 17687781
• MDR Text Key: 322943570
• Report Number: 2029046-2023-01998
• Device Sequence Number: 1
• Product Code: MTD
• UDI-Device Identifier: 10846835012255
• UDI-Public: 10846835012255
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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,Followup,Followup
• Report Date: 10/25/2023

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 Catalogue Number: D128211
• Device Lot Number: 31058890L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/08/2023
• Initial Date FDA Received: 09/05/2023
• Supplement Dates Manufacturer Received: 10/16/2023; 10/24/2023
• Supplement Dates FDA Received: 10/17/2023; 10/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/25/2023
• 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: 8.5F SHEATH WITH CURVE VIZ MDC