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

Catalog Number D142901

Device Problem Obstruction of Flow (2423)

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

Event Date 03/26/2024

Event Type  malfunction  

Manufacturer Narrative

E1: (b)(6).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).

Event Description

It was reported that a patient underwent an atrial fibrillation ablation procedure with a optrell mapping catheter with trueref technology and irrigation was not coming out of the tip lumen.Pump was not used.It was dripped under pressure.It was coming out at the beginning of the procedure but ceased when switching catheters after pre-mapping.No optrell catheter settings were installed on the generator.The issue was resolved by replacing the optrell to another new one.The procedure was completed without patient's consequence.

Manufacturer Narrative

On 6-may-2024, the bwi product analysis lab received the device for evaluation.The product investigation was subsequently completed.It was reported that a patient underwent an atrial fibrillation ablation procedure with a optrell mapping catheter with trueref technology and irrigation was not coming out of the tip lumen.Pump was not used.It was dripped under pressure.It was coming out at the beginning of the procedure but ceased when switching catheters after pre-mapping.No optrell catheter settings were installed on the generator.The issue was resolved by replacing the optrell to another new one.The procedure was completed without patient's consequence.Device evaluation details: the device was returned to biosense webster (bwi) for evaluation.A visual inspection evaluation and irrigation test of the returned device were performed following bwi procedures.Visual analysis of the returned sample revealed no anomalies or damages in the device.An irrigation test was performed, and during the test, an occlusion was detected.Further investigation revealed that the irrigation tube was bent close to the tip section.A manufacturing record evaluation was performed for the finished device 31182872m number, and no internal actions related to the reported complaint condition were identified.Since the irrigation tube was found bent close to the tip section, this failure could be related to the issue reported by the customer; therefore, the customer complaint was confirmed.The bent condition observed could not be determined.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: 19140593
• MDR Text Key: 340877866
• Report Number: 2029046-2024-01298
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 10846835025828
• UDI-Public: 10846835025828
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K230253
• 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: 04/18/2024

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: 31182872M
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/18/2024
• Was Device Evaluated by Manufacturer?: No
• 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