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

Model Number	D140902
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an ischemic ventricular tachycardia (isvt) ablation procedure with a optrell mapping catheter with trueref technology and a medical device entrapment (no excessive manipulation required) issue occurred.It was reported that while doing an early evaluation study, the optrell catheter became entangled with an impella device in the patient's left ventricle.They were able to advance the impella device and undeflect and withdraw the optrell catheter.The patient was stable.They continued the case using an octaray catheter.The case continued without any further incident.The physician stated they would not be using the optrell catheter in the future with a patient that has an impella device.There was difficulty maneuvering catheter while entangled.The device was able to be withdrawn when impella was advanced.There was no detachment of any component.The loop/tip was not knotted, just entangled.They were able to remove the optrell safely with impella still in place.The issue did not result in exposure of any internal catheter components or sharp edges.There was no patient consequence.The medical device entrapment (no excessive manipulation required) issue is mdr reportable.
Additional Manufacturer Narrative
A x-ray video was received for evaluation following biosense webster's procedures.According to video provided by the customer, the optrell catheter was observed entangled with another device inside the patient's body.The product was returned to biosense webster (bwi) for evaluation.Bwi conducted a visual inspection of the returned device.Visual analysis revealed no damage or anomalies on the device.No malfunction was observed during the product analysis.A manufacturing record evaluation was performed for the finished device 30768962m number, and no internal action was found during the review.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.The instructions for use contain the following warnings and precautions; prior to removing or repositioning the catheter, use direct imaging guidance such as fluoroscopy or ultrasound to confirm that the spine assembly is not entangled with another catheter or with an anatomical structure.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Explanation of codes: investigation findings: no device problem found (c19) / investigation conclusions: no problem detected (d14) were selected as related to the customer¿s reported medical device entrapment (no excessive manipulation required) issue.Investigation findings: appropriate term/code not available (c22) / investigation conclusions: cause not established (d15) were selected as related to the x-ray/video analysis.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: pc-001235807.

• 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: 17238320
• Report Number: 2029046-2023-01432
• Device Sequence Number: 7090741
• Product Code: DRF
• UDI-Device Identifier: 10846835023022
• UDI-Public: 10846835023022
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K211439
• 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
• Report Date (Section B): 06/30/2023

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: 03/21/2023
• Device Model Number: D140902
• Device Catalogue Number: D140902
• Device Lot Number: 30768962M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2022
• Initial Report FDA Received Date: 06/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/22/2022
• 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: UNK IMPELLA DEVICE; UNK_CARTO VIZIGO SHEATH; UNK_OCTARAY NAV
• Patient Sex: Unknown