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

Model Number	D140901
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an atrioventricular nodal reentrant tachycardia (avnrt) procedure with an optrell catheter and a medical device entrapment issue occurred.During the procedure, the vizigo, optrell, and quadripolar catheters became entangled.The physician was able to manually maneuver the catheters and resolve the entanglement.The procedure continued.No adverse consequences to the patient.Documentation purposes only.No catheters are available for return.No replacement catheters or further actions are being requested.Additional information was received.The damage did not result in wires being exposed.The damage did not result in any lifted or sharp rings.He had difficulty to remove the catheter because it was tangled with quadripolar catheter.Picture provided.The catheter was not pre-shaped.The event was assessed as mdr reportable for a medical device entrapment issue.
Additional Manufacturer Narrative
The product was discarded, therefore no product failure analysis can be conducted and device malfunction cannot be confirmed.  a picture was 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.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).
Additional Manufacturer Narrative
It was reported that a patient underwent an atrioventricular nodal reentrant tachycardia (avnrt) procedure with an optrell catheter.During the procedure, the vizigo, optrell, and quadripolar catheters became entangled.The physician was able to manually maneuver the catheters and resolve the entanglement.The procedure continued.No adverse consequences to the patient.Additional information was received.The damage did not result in wires being exposed.The damage did not result in any lifted or sharp rings.He had difficulty to remove the catheter because it was tangled with quadripolar catheter.The catheter was not pre-shaped.The picture evaluation was completed on 12-jul-2023.A picture was received for evaluation following biosense webster's procedures.According to the picture provided by the customer, the splines of the paddle were observed with a bent condition.This could be the result of the entrapment condition reported by the customer; however, this cannot be conclusively determined.Although the splines were observed bent, no damages or anomalies were observed on the electrodes.A manufacturing record evaluation was performed, and no internal actions related to the reported complaint condition were identified.The customer complaint was confirmed based on the picture received.The product was discarded; therefore, no product failure analysis can be conducted.H6.Investigation findings code of ¿appropriate term/code not available¿ represents photo/video analysis.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
• 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: 17187302
• Report Number: 2029046-2023-01358
• Device Sequence Number: 6808905
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2023

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: 08/05/2023
• Device Model Number: D140901
• Device Catalogue Number: D140901
• Device Lot Number: 30873142M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2023
• Supplement Date Received by Manufacturer: 07/12/2023
• Initial Report FDA Received Date: 06/22/2023
• Supplement Report FDA Received Date: 08/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/06/2022
• 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: QUADRIPOLAR CATHETER; UNK_CARTO VIZIGO SHEATH
• Patient Sex: Unknown