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

Catalog Number D142901

Device Problems Contamination /Decontamination Problem (2895); Device-Device Incompatibility (2919)

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

Event Date 02/29/2024

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrioventricular nodal reentrant tachycardia (avnrt) ablation procedure with a optrell mapping catheter with trueref technology and a round plastic piece ¿bead¿ like material was found on the tip of the catheter.It was reported that the optrell mapping catheter with trueref technology would not properly advance into the sheath.The caller noted that the sheath was "locking." the sheath was replaced with a "non-locking" sheath, but the issue persisted.The caller reported that it was noticed there was a "round plastic piece," almost like a "bead," on the end of the optrell mapping catheter with trueref technology introducer.The round plastic piece was removed from the tip of the introducer, and the issue was resolved.The procedure continued.There was no patient consequence.There was resistance maneuvering the optrell mapping catheter with trueref technology when the foreign material was on the catheter tip.Once it was removed they had no problems.

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 atrioventricular nodal reentrant tachycardia (avnrt) ablation procedure with a optrell mapping catheter with trueref technology and a round plastic piece ¿bead¿ like material was found on the tip of the catheter.It was reported that the optrell mapping catheter with trueref technology would not properly advance into the sheath.The caller noted that the sheath was "locking." the sheath was replaced with a "non-locking" sheath, but the issue persisted.The caller reported that it was noticed there was a "round plastic piece," almost like a "bead," on the end of the optrell mapping catheter with trueref technology introducer.The round plastic piece was removed from the tip of the introducer, and the issue was resolved.The procedure continued.There was no patient consequence.Device investigation details: the product has not returned for analysis, however, a picture was provided by the customer.According to the pictures provided by the customer, a foreign material was observed, the material looks like a part of a luer hub component; however, based on the characteristics of the foreign material this does not belong to a component of an optrell catheter, the source of the foreign material remains unknow, it is likely to belong to another device used during the procedure; however, this cannot be conclusively at this time.The foreign material could be related to the resistance condition reported by the customer during the procedure.A manufacturing record evaluation was performed, and no internal action related to the reported complaint condition were identified.The customer complaint was confirmed based on the picture received.The device has not been returned for analysis and a root cause is unable to be assigned based on the current evidence.If the device is received in the future, the product investigation will be performed and updated accordingly, and any action will be taken if necessary.Note: h6.Investigation findings code of ¿appropriate term/code not available (c22)¿ used to represent the photo analysis results.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 14-may-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.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: 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: 18957777
• MDR Text Key: 339229064
• Report Number: 2029046-2024-00980
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 10846835025828
• UDI-Public: 10846835025828
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K230253
• 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: 03/22/2024

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: D142901
• Device Lot Number: 31115952M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/29/2024
• Initial Date FDA Received: 03/22/2024
• Supplement Dates Manufacturer Received: 04/03/2024; 05/14/2024
• Supplement Dates FDA Received: 04/24/2024; 05/15/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/24/2023
• 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