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

Catalog Number	D140901
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that a patient underwent an idiopathic ventricular tachycardia (idvt) procedure with a optrell mapping catheter with trueref technology.The optrell mapping catheter with trueref technology lumen became occluded during use in the patient, though it was being irrigated with heparinized saline at a kvo rate.They removed the catheter, attempted to flush it manually but it was completely occluded.They exchanged the catheter to continue the procedure.There was no patient consequence reported.The device evaluation was completed 31-may-2024.The product was returned to biosense webster (bwi) for evaluation.A visual inspection and irrigation test of the returned device were performed following bwi procedures.Visual analysis revealed no damage or anomalies on the device.The irrigation test was performed and it was not flushing correctly since the irrigation tube was bent inside the handle.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The irrigation issue reported by the customer was confirmed due to the bent irrigation tube found inside the handle.The potential cause of the bent irrigation tube could not be conclusively determined.The instruction for use (ifu) contains the following warning and precautions: prior to inserting the catheter into the body, flush the catheter with heparinized normal saline.Always follow standard practices of using a continuous drip of anticoagulant fluid under pressure through the irrigation luer when the catheter is in the body.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).
Additional Manufacturer Narrative
If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.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 or Problem Description
It was reported that a patient underwent an idiopathic ventricular tachycardia (idvt) procedure with a optrell mapping catheter with trueref technology and it became occluded during use in the patient.The optrell mapping catheter with trueref technology lumen became occluded during use in the patient, though it was being irrigated with heparinized saline at a kvo rate.They removed the catheter, attempted to flush it manually but it was completely occluded.They exchanged the catheter to continue the procedure.There was no patient consequence reported.Additional information was received.The suspected device for the reported issue was the catheter.Issue was discovered with flushing the optrell mapping catheter with trueref technology using a syringe prior to connecting to a pump.No error on the pump.They replaced the catheter with no issue.They did not utilize the generator at all.
Additional Manufacturer Narrative
The bwi product analysis lab received the device for evaluation on 16-may-2024.The 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 reference number: (b)(4).

• Brand Name: OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY
• Common Device Name: 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 ; MX
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 19323220
• Report Number: 2029046-2024-01586
• Device Sequence Number: 6320607
• Product Code: DRF
• UDI-Device Identifier: 10846835023015
• UDI-Public: 10846835023015
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K211438
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/26/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/28/2024
• Device Catalogue Number: D140901
• Device Lot Number: 31070517M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2024
• Supplement Date Received by Manufacturer: 05/16/2024; 05/31/2024
• Initial Report FDA Received Date: 05/15/2024
• Supplement Report FDA Received Date: 05/20/2024; 06/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/29/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown