MAUDE Adverse Event Report: BIOSENSE WEBSTER INC OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Catalog Number D140901

Device Problem Contamination (1120)

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

Event Date 10/26/2023

Event Type  malfunction  

Event Description

It was reported that a patient underwent a cardiac ablation procedure with a optrell mapping catheter with trueref technology and post procedure the bwi product analysis lab identified that there was a white material was found trapped in the electrodes.An analysis was performed and determined that the white material's composition was principally composed of polystyrene base material.The origin of this material is unknown.During the procedure itself, the optrell was inserted into the patient's body, and mapping of the right atrium was performed.The optrell spines were not displayed in the mapping phase.Reset visualization was performed and the cable was replaced.Study was exit, and reloading was performed but the issue did not resolve.The issue was resolved by replacing the optrell to another new one.Tissue like cardiac muscle was attached to the optrell's tip.The procedure was then completed, and when the second optrell was removed, similar tissue was identified.No patient consequences were reported.

Manufacturer Narrative

E1 initial reporter phone: (b)(6).The product investigation was completed.Device evaluation details: the product was returned to biosense webster for evaluation.Bwi conducted a visual inspection.Visual analysis of the returned sample revealed no biological material was found, and no physical damage was observed.However, a white material was found trap in electrodes and it was sent to fourier transform infra-red analysis to know its composition which was principally composed of polystyrene base material.The origin remains unknown.Visual inspection testing was performed, in accordance with bwi procedures.The event described, could not be confirmed.Although no biological material was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the analysis.A manufacturing record evaluation was performed for the finished device number, 31121197m, and no internal actions related to the complaint were found during the review.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 reference number: (b)(4).

• Brand Name: OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY
• 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: 18839682
• MDR Text Key: 336966643
• Report Number: 2029046-2024-00731
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 10846835023015
• UDI-Public: 10846835023015
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K211438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/05/2024

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: D140901
• Device Lot Number: 31121197M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2023
• Initial Date Manufacturer Received: 02/09/2024
• Initial Date FDA Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/28/2023
• 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: OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY