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	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient with dual chamber implantable cardioverter defibrillator (icd) underwent an idiopathic ventricular tachycardia (idvt) ablation procedure with an optrell mapping catheter with trueref technology and when taking the catheter out of the body resistance was met.It was reported that when taking the optrell mapping catheter with trueref technology catheter out of the body, he was meeting some resistance at the inferior vena cava (ivc) level on carto when removing the catheter, however, he elected to advance and then was able to withdraw after a couple of times advancing to the superior vena cava (svc) via catheter visualization on the catheter.The catheter was moved superior to inferiorly several times and the catheter was able to be withdrawn from the body.Then implanted aicd was then interrogated and the atrial lead would not pace.The heart was then x-rayed and the atrial lead was dislodged.The patient is stable.A lead revision is being scheduled.The physician discharged the patient that evening.
Additional 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).
Additional Manufacturer Narrative
On 3-oct-2023, 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.Additionally, the manufactured date and expiration date have been provided.Therefore, fields d4.Expiration date and h4.Device manufacture date have been populated.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.#(b)(4).
Additional Manufacturer Narrative
It was reported that a patient with dual chamber implantable cardioverter defibrillator (icd) underwent an idiopathic ventricular tachycardia (idvt) ablation procedure with an optrell mapping catheter with trueref technology and when taking the catheter out of the body resistance was met.It was reported that when taking the optrell mapping catheter with trueref technology catheter out of the body, he was meeting some resistance at the inferior vena cava (ivc) level on carto when removing the catheter, however, he elected to advance and then was able to withdraw after a couple of times advancing to the superior vena cava (svc) via catheter visualization on the catheter.The catheter was moved superior to inferiorly several times and the catheter was able to be withdrawn from the body.Device evaluation details: the device was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.Visual inspection, deflection, and outer diameter (od) test of the returned device were performed following bwi procedures.Visual analysis revealed no damage or anomalies on the device.A deflection test was performed, and the curve was deflecting within specifications.No deflection issues were observed.Outer diameter test was performed and measurements are within specifications.A manufacturing record evaluation was performed and no internal actions related to the reported complaint condition were identified.The issue reported by the customer could not be replicated during the product investigation; other issues or circumstances may have occurred during the usage of the device that compromised its performance.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 ref.# (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 32599 ; MX 32599
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 17808845
• Report Number: 2029046-2023-02161
• Device Sequence Number: 15249861
• Product Code: DRF
• UDI-Device Identifier: 10846835023015
• UDI-Public: 10846835023015
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/25/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/01/2024
• Device Catalogue Number: D140901
• Device Lot Number: 31070528M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2023
• Supplement Date Received by Manufacturer: 10/03/2023; 10/12/2023
• Initial Report FDA Received Date: 09/25/2023
• Supplement Report FDA Received Date: 10/04/2023; 10/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/02/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 8.5F SHEATH WITH CURVE VIZ MDC; SOUNDSTAR ECO SMS 10F CATHETER; THMCL SMTCH SF BID, TC, D-F
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 80 KG