MAUDE Adverse Event Report: BIOSENSE WEBSTER INC OPTRELL, 48 ELECTRODES, D-F; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number D140901

Device Problems Display or Visual Feedback Problem (1184); Contamination /Decontamination Problem (2895)

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

Event Date 09/16/2022

Event Type  malfunction  

Event Description

A patient underwent an ablation procedure with a optrell catheter for which biosense webster¿s product analysis lab identified during microscopic analysis that electrodes a1 and a2 were lightly lifted and foreign material was found under the electrodes.The finding was identified on (b)(6) 2022.It was reported that the splines of the optrell catheter were disappearing on the carto 3 system.The medical team tried disconnecting the ultrasound catheter with no resolution.They turned off the trueref electrode with no resolution.They reset the visualization matrix and the issue still remained.After replacing the catheter cable, the issue persisted.There was also issues with visualization so the physician requested to switch to the octaray catheter.No other issues were reported using the octaray catheter.No patient consequences were reported.Visualization issue is not mdr-reportable.Foreign material is mdr-reportable.

Manufacturer Narrative

The product investigation was completed.Device evaluation details: visual analysis revealed no damage or anomalies on the device.A magnetic sensor functionality test was performed and the device was recognized on the system; however, the device could not be visualized but the noise was observed on electrodes a1 and a2.A microscopic examination reveals that this electrode was lifted by a polyurethane-based material related to the introduced causing an open circuit on the tip area.This open circuit could be related to the improper visualization of the device.A manufacturing record evaluation was performed for the finished device 30842502m number, and no internal actions related to the reported complaint condition were identified.The issue reported by the customer was confirmed.It should be noted that product failure is multifactorial.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

On 20-jun-2023, bwi received additional information indicating that the abbott esl 0/1 short sheath was used during the procedure.It has been added to the concomitant products 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: OPTRELL, 48 ELECTRODES, D-F
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• 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: 16128811
• MDR Text Key: 306979524
• Report Number: 2029046-2023-00064
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 10846835023015
• UDI-Public: 10846835023015
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K211438
• 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
• Report Date: 07/17/2023

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 Expiration Date: 06/29/2023
• Device Model Number: D140901
• Device Catalogue Number: D140901
• Device Lot Number: 30842502M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/13/2022
• Initial Date FDA Received: 01/10/2023
• Supplement Dates Manufacturer Received: 06/20/2023
• Supplement Dates FDA Received: 07/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2022
• 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: ABBOTT ESL 0/1 SHORT SHEATH; CARTO 3 SYSTEM; CARTO 3 SYSTEM ECO INTERFACE CABLE; OCTARAY CATHETER; OPTRELL ELECTRODES