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

Model Number D134301

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 12/13/2022

Event Type  malfunction  

Manufacturer Narrative

Requested clarification as an alert date update was received from (b)(6) 2022 to (b)(6) 2022; however, the event date and received date of the complaint provided is (b)(6) 2022.The picture investigation was completed on (b)(6) 2022.According to the pictures provided by the customer, the tip was detached from the shaft of the device.A manufacturing record evaluation was performed, and no internal actions related to the reported complaint were identified.The customer complaint was confirmed from the photo analysis.However, the device has not been returned for evaluation.Since no device has been received, no product investigation can be performed.If the device is received in the future, the product analysis will be performed as appropriate in order to find the root cause of the complaint.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).

Event Description

It was reported that a patient underwent an ablation procedure with a lasso® nav eco variable catheter and the tip fully separated.It was reported that when the package was opened, the operators noticed that the blue distal tip was separated from the rest of the catheter.The catheter was not used on the patient.It was put aside and the procedure continued with a similar device.Additional information was received.The damage resulted in wires being exposed but did not result in any lifted or sharp rings.The catheter was not inserted in the patient.The issue was found when the catheter was extracted from the box, the distal end was separated from the rest.Pictures were provided.Catheter was not pre-shaped.Sheath information not available.The event was assessed as mdr reportable for a tip fully separated issue.

Manufacturer Narrative

In the 3500a initial, it was reported that we requested clarification as an alert date update was received from 13-dec-2022 to 19-dec-2022; however, the event date and received date of the complaint provided is 13-dec-2022.Clarification was received on 11-jan-2023 stating that the correct alert date and received date is 20-dec-2022.Therefore, the g3.Date received by manufacturer field in the 3500a initial should have reflected as 20-dec-2022.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

The bwi product analysis lab received the device for evaluation on 02-feb-2023.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

It was reported that a patient underwent an ablation procedure with a lasso® nav eco variable catheter and the tip fully separated.The device evaluation was completed on 17-mar-2023.The device was returned to biosense webster for evaluation.A visual inspection, of the returned device were performed in accordance with bwi procedures.Visual analysis revealed that the tip was broken in the transition tip to shaft.For this condition, a manufacturing investigation was performed.No other damage or traces related to the failure were observed.A manufacturing record evaluation was performed for the finished device, and no internal action was found during the review.The issue reported by the customer was confirmed.The cause of the failure documented in this product complaint could not be related to the manufacturing process since the device was analyzed and fully observed a tangible manipulation on the transition between shaft and tip.The investigation was performed to ensure that the catheter was manufactured according to the process instructions and complied with the quality requirements previous to release.It appears to be linked to external manipulation due to the exhaustive prevention process instructions during the manufacturing process.As part of biosense webster's quality process, all devices are manufactured, inspected, and released to approved specifications.This product issue will be addressed through bwi's quality system.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
• Type of Device: 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 ; MX
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 16129009
• MDR Text Key: 308642685
• Report Number: 2029046-2023-00068
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 10846835009637
• UDI-Public: 10846835009637
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K113213
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/12/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 02/25/2024
• Device Model Number: D134301
• Device Catalogue Number: D134301
• Device Lot Number: 30521095L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/13/2022
• Initial Date FDA Received: 01/10/2023
• Supplement Dates Manufacturer Received: 01/11/2023; 02/02/2023; 03/17/2023
• Supplement Dates FDA Received: 01/11/2023; 02/10/2023; 04/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/26/2021
• 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
• Treatment: UNKNOWN BRAND CATHETER; UNKNOWN BRAND SHEATH