MAUDE Adverse Event Report: BIOSENSE WEBSTER INC LASSO® 2515 NAV VARIABLE CATHETER; ELECTRODE RECORDING CATHETER OR ELECTRODE RECORDING PROBE

Model Number LN222515CT

Device Problem Mechanical Jam (2983)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/01/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(6).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 Description

It was reported that an unknown patient underwent an atrial fibrillation (afib) ablation procedure with a lasso® 2515 nav variable catheter.The deflection was stuck.Lasso curve can't do d curve, and release curve can't go back to normal position.No patient consequences were reported.Stuck deflation is mdr-reportable.

Manufacturer Narrative

On 17-nov-2021, 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).

Manufacturer Narrative

On 13-dec-2021, the product investigation was completed.It was reported that an unknown patient underwent an atrial fibrillation (afib) ablation procedure with a lasso® 2515 nav variable catheter.The deflection was stuck.Lasso curve can't do d curve and release curve can't go back to normal position.No patient consequences were reported.Device evaluation details: visual analysis of the returned sample revealed that no damage or anomalies were observed on the lasso nav catheter.Deflection testing was performed and observed that the tip deflects properly.The event described could not be confirmed as the device performed without any 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.A manufacturing record evaluation was performed for the finished device 30260540l number, and no internal action was found during the review.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® 2515 NAV VARIABLE CATHETER
• Type of Device: ELECTRODE RECORDING CATHETER OR ELECTRODE RECORDING PROBE
• 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 ; MX
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 12613577
• MDR Text Key: 283301634
• Report Number: 2029046-2021-01741
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 10846835008296
• UDI-Public: 10846835008296
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K081258
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/03/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2022
• Device Model Number: LN222515CT
• Device Catalogue Number: LN222515CT
• Device Lot Number: 30260540L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/24/2021
• Initial Date FDA Received: 10/12/2021
• Supplement Dates Manufacturer Received: 11/17/2021; 12/13/2021
• Supplement Dates FDA Received: 12/06/2021; 01/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/02/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1