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

Catalog Number D160904

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

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

Event Date 01/16/2024

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) procedure with an octaray mapping catheter and the electrode was damaged with a clear fibrous thread from the electrode area.The catheter was withdrawn from the patient and they found a clear fibrous thread from the electrode area and a slightly bent electrode.The octaray mapping catheter was replaced and the procedure continued.There was no patient consequence reported.Additional information was received.The octaray mapping catheter was inserted into the left atrium for mapping and they saw noise on e3,4 and e4,5 immediately.The physician decided to hide those electrodes.He took out the octaray mapping catheter after mapping to exchange with the ablation and saw the damaged octaray mapping catheter.Did not see any exposed wires due to the damage.The rings did not seem sharp but it did seem like one of the splines was warped.Caller did not know if there was difficulty inserting or removing the catheter.The issue was at the distal end of the catheter.The catheter was not pre-shaped.The vizigo 8.5 small curve sheath was used.The noise issue was assessed as non mdr reportable.The risk to the patient was low.The electrode was damaged with a clear fibrous thread from the electrode area was assessed as mdr reportable.

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.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).

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on 04-mar-2024.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.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

It was reported that a patient underwent an atrial fibrillation (afib) procedure with an octaray mapping catheter.The catheter was withdrawn from the patient and they found a clear fibrous thread from the electrode area and a slightly bent electrode.The octaray mapping catheter was replaced and the procedure continued.There was no patient consequence reported.Additional information was received.The octaray mapping catheter was inserted into the left atrium for mapping and they saw noise on e3,4 and e4,5 immediately.The physician decided to hide those electrodes.He took out the octaray mapping catheter after mapping to exchange with the ablation and saw the damaged octaray mapping catheter.Did not see any exposed wires due to the damage.The rings did not seem sharp but it did seem like one of the splines was warped.Caller did not know if there was difficulty inserting or removing the catheter.The issue was at the distal end of the catheter.The catheter was not pre-shaped.The vizigo 8.5 small curve sheath was used.The device evaluation was completed on (b)(6) 2024.The product was returned to biosense webster (bwi) for evaluation.A visual inspection and electrical evaluation of the returned device were performed following bwi procedures.Visual analysis of the returned sample revealed several electrodes lifted in one of the splines.Also, a plastic foreign material was found attached.An electrical test was performed and an open circuit was found in the tip section.Due to the material found attached, a fourier transform infrared spectroscopy (ft-ir) analysis was requested and the results determined that the transparent foreign material is mainly composed of polytetrafluoroethylene (ptfe) based material.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The customer complaint was confirmed based on the results observed during the visual and electrical test.The ptfe particle could be related to the interaction with the sheath during the procedure; however, this cannot be conclusively determined.The instructions for use contain the following recommendations: do not introduce the catheter into a guiding sheath with the catheter¿s distal splines folded back toward the handle.Collapse the splines together using the insertion tube prior to insertion as part of biosense webster's quality process, all devices are manufactured, inspected, and released to approved specifications.This product issue will be addressed through bwi's quality system.Explanation of codes: -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 ¿clear fibrous thread from the electrode area and a slightly bent electrode¿.In addition, biosense webster inc.Analysis finding of the ¿several electrodes lifted¿.-investigation findings: inappropriate material (c0602) / investigation conclusions: cause not established (d15) / component code: electrode (g0201501) were selected as related to the customer¿s reported ¿clear fibrous thread from the electrode area and a slightly bent electrode¿.In addition, biosense webster inc.Analysis finding of the ¿plastic foreign material was found attached¿.-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 ¿noise¿ issue.In addition, biosense webster inc.Analysis finding of the ¿open circuit was found in the tip section¿.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: OCTARAY MAPPING 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: 18655409
• MDR Text Key: 334842983
• Report Number: 2029046-2024-00404
• Device Sequence Number: 1
• Product Code: MTD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193237
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: D160904
• Device Lot Number: 31197571L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/15/2023
• 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 SMC.