MAUDE Adverse Event Report: BIOSENSE WEBSTER INC LASSO NAV ECO VARIABLE CATHETER; CATHETER, ELECTRODE RECORDING OR PROBE, ELECTRODE RECORDING

Model Number	D134302
Medical Device Problem Codes	Entrapment of Device (1212); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event year was reported as 2020.The bwi product analysis lab received the device for evaluation.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).
Event or Problem Description
It was reported that a patient underwent a procedure with a lasso® nav eco variable catheter and a contraction stuck issue occurred.During the procedure, the lasso® nav eco variable catheter got stuck while moving.The catheter was not changed and the procedure could be completed with no patient consequences.Additional clarification was received on the event.The loop of the lasso® nav eco variable catheter got stuck in a fully contracted position.The knob/piston was unable to be pushed up and down.There was no difficulty on removing the catheter from the patient¿s body.The event was assessed as a mdr reportable contraction stuck issue.
Additional Manufacturer Narrative
Initially it was reported that a patient underwent a procedure with a lasso® nav eco variable catheter and a contraction stuck issue occurred.There was no difficulty on removing the catheter from the patient¿s body.Additional information was received on (b)(6) 2021 clarifying that two issues occurred during the procedure as the catheter became stuck inside the patient¿s body due to the loop being stuck in a contracted position.The additional information describing also a medical device entrapment issue as the catheter was stuck inside the patient¿s body was assessed as not mdr reportable.The device was removed without surgical intervention, or without using a different device, the potential risk that it could cause or contribute to a serious injury or death to the operator or patient was remote.Therefore, added under ¿h6.Medical device problem code¿ ¿entrapment of device¿.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
It was reported that a patient underwent a procedure with a lasso® nav eco variable catheter.During the procedure, the lasso® nav eco variable catheter got stuck while moving.The catheter was not changed and the procedure could be completed with no patient consequences.Additional clarification was received on the event.The loop of the lasso® nav eco variable catheter got stuck in a fully contracted position.The knob/piston was unable to be pushed up and down.There was no difficulty on removing the catheter from the patient¿s body.Additional information was received on clarifying that two issues occurred during the procedure as the catheter became stuck inside the patient¿s body due to the loop being stuck in a contracted position.The device evaluation was completed on 4/16/2021.The product was returned to biosense webster for evaluation.Bwi conducted a general inspection through the visual inspection and deflection/contraction test of the catheter.Visual analysis of the returned sample revealed that no damage or anomalies were observed on the lasso nav variable eco.Per the event, the deflection and contraction test was performed in accordance with bwi procedures.The device was contracted correctly and passed the test.No issues were found.In the same way, the deflection test was performed finding that the curve met the specifications.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.As part of bwi¿s quality process all devices are manufactured, inspected, and released to approved specifications.No deflection or contraction issues related to the reported event were found.The instructions for use contain the following information that should be considered: confirm that the thumb knob is pulled back completely before insertion and that the loop-contraction mechanism is not activated, ensuring minimal tension to the nitinol loop.The event described could not be confirmed as the as the device performed without any contraction or deflection issues.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.Originally the lot number was not known.During the device analysis the lot number was retrieved.Therefore, updated d4.Lot, d4.Expiration date and h4.Device manufacture date.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: LASSO NAV ECO VARIABLE CATHETER
• Common Device Name: CATHETER, ELECTRODE RECORDING OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 11498912
• Report Number: 2029046-2021-00374
• Device Sequence Number: 2855298
• Product Code: DRF
• UDI-Device Identifier: 10846835009644
• UDI-Public: 10846835009644
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K113213
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/17/2021

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: 11/11/2023
• Device Model Number: D134302
• Device Catalogue Number: D134302
• Device Lot Number: 30476714L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2021
• Supplement Date Received by Manufacturer: 03/17/2021; 04/16/2021
• Initial Report FDA Received Date: 03/16/2021
• Supplement Report FDA Received Date: 04/13/2021; 05/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1