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

Catalog Number D160903

Device Problems Contamination /Decontamination Problem (2895); Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 12/13/2023

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a octaray mapping catheter and it looked like it may be some sort of ¿resin¿ like material on the device.It was also reported by the bwi representative that upon opening the package for the octaray mapping catheter they noticed some "fabric or some type of resin" embedded on the device; on the electrodes.Upon replacing the catheter the issue was resolved and the procedure continued.There was no patient consequence.Additional information was later received indicating the device was used on the patient and the issue was not noticed prior to use on patient.As such, follow up for clarification is in progress.

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.Manufacturer's ref.(b)(4).

Manufacturer Narrative

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a octaray mapping catheter and it looked like it may be some sort of ¿resin¿ like material on the device.It was also reported by the bwi representative that upon opening the package for the octaray mapping catheter they noticed some "fabric or some type of resin" embedded on the device; on the electrodes.Upon replacing the catheter the issue was resolved and the procedure continued.There was no patient consequence.Device evaluation details: the product was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.A visual inspection evaluation of the returned device was performed following bwi procedures.Visual analysis of the returned sample revealed a plastic foreign material attached to the splines.For this reason, a fourier transform infrared spectroscopy (ft-ir) was requested, and the analysis revealed that the foreign material showed the absorption bands for polytetrafluoroethylene (ptfe) based material.Since ptfe material was found, an eeprom integrity test verification was performed and it was confirmed that the device was used.Additionally, a picture was received for evaluation.According to pictures provided by the customer, a large foreign material was observed next with the octaray.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The issue reported by the customer was confirmed.The ptfe particle could be related to the interaction with the sheath; 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 spines folded back toward the handle.Collapse the spines 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.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

On 22-feb-2024, 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.Additionally, the manufactured date and expiration date have been provided.Therefore, fields d4.Expiration date and h4.Device manufacture date have been populated.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: 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: 18491377
• MDR Text Key: 332618399
• Report Number: 2029046-2024-00147
• Device Sequence Number: 1
• Product Code: MTD
• UDI-Device Identifier: 10846835021127
• UDI-Public: 10846835021127
• 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: 01/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: D160903
• Device Lot Number: 31144741L
• 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: 09/05/2023
• 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: CARTO 3 SYSTEM; NGEN PUMP, US CONFIGURATION; SOUNDSTAR ECO CABLE ASSY 10 FT