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	06/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an idiopathic ventricular tachycardia (left) ablation procedure with an optrell mapping catheter with trueref technology and the catheter got stuck in patient.It was reported by the caller, the bwi representative, that during a procedure an adverse event occurred.They were performing a premature ventricular contraction (pvc) procedure and the optrell catheter got stuck as they were trying to pull it out and replace it with the ablator.The caller reported that when they withdrew the catheter, they pulled it through the aorta, and it came out fine, but it had folded back on itself as the physician was coming down the artery and they could not get it out.The caller reported that the physician "brought fluoro down and noticed the catheter was folded back on itself." the caller reported that they tried moving the sheath and the catheter, they tried withdrawing the sheath and pulling the catheter out and still could not move it.The physician was nervous to use force and the physician called for ct support and interventional radiology backup.The caller reported that they finally were able to pull it out and it finally folded back on itself.The caller reported that he did "not believe there was any malfunction with the catheter, but that it just got jammed when it retroflexed on itself." the caller reported no injury to the patient, no patient symptoms, and no medical intervention that was provided.Additional information was later received indicating that with more force, the catheter un-retroflexed on itself and was able to be removed.The physician was hesitant to pull harder because we were in the artery.None of the electrodes looked/damage.The same goes for the catheter itself.Nothing detached nor exposed components.It was not believe anything was wrong with the catheter.
Additional Manufacturer Narrative
The product has not returned for analysis, however, pictures were provided by the customer.Evaluation is still in progress.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.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
It was reported that a patient underwent an idiopathic ventricular tachycardia (left) ablation procedure with an optrell mapping catheter with trueref technology and the catheter got stuck in patient.It was reported by the caller, the bwi representative, that during a procedure an adverse event occurred.They were performing a premature ventricular contraction (pvc) procedure and the optrell catheter got stuck as they were trying to pull it out and replace it with the ablator.The caller reported that when they withdrew the catheter, they pulled it through the aorta, and it came out fine, but it had folded back on itself as the physician was coming down the artery and they could not get it out.The caller reported that the physician "brought fluoro down and noticed the catheter was folded back on itself." the caller reported that they tried moving the sheath and the catheter, they tried withdrawing the sheath and pulling the catheter out and still could not move it.The physician was nervous to use force and the physician called for ct support and interventional radiology backup.The caller reported that they finally were able to pull it out and it finally folded back on itself.The caller reported that he did "not believe there was any malfunction with the catheter, but that it just got jammed when it retroflexed on itself." the caller reported no injury to the patient, no patient symptoms, and no medical intervention that was provided.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.Additionally, according to the picture and video provided by the customer, there is insufficient information related to the adverse event reported by the customer; and therefore no results can be obtained.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).
Additional Manufacturer Narrative
On 9-aug-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.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: 17390398
• Report Number: 2029046-2023-01577
• Device Sequence Number: 20544184
• 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): 09/18/2023

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: 09/11/2023
• Device Catalogue Number: D140901
• Device Lot Number: 30906357M
• 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: 06/28/2023
• Supplement Date Received by Manufacturer: 08/09/2023; 08/21/2023
• Initial Report FDA Received Date: 07/25/2023
• Supplement Report FDA Received Date: 08/14/2023; 09/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/12/2022
• 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: CARTO 3 SYSTEM; UNKNOWN 8.5 FR SHORT SHEATH; UNKNOWN ABLATION CATHETER
• Patient Sex: Unknown