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

Catalog Number D134301

Device Problems Hole In Material (1293); Device Handling Problem (3265)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/19/2017

Event Type  malfunction  

Manufacturer Narrative

The bwi failure 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.The device history record (dhr) was reviewed and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.(b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) procedure with a lasso® nav eco variable catheter and a contraction issue occurred as the loop diameter was not changing normally.The movement was abnormal when reducing the diameter of the loop.The curve of the catheter was not stuck/jammed in a full deflected/contracted position.The knob/piston could be turned and/or pushed up and down.There was no difficulty in removing the catheter.There was no ring or other physical damage observed at the distal end of the catheter.The issue was resolved by changing the catheter to another one.The procedure was completed with no patient consequence.This event was originally assessed as not mdr reportable because the potential risk that it could cause or contribute to a serious injury or death is remote.The device was returned to the biosense webster failure analysis lab and on march 16, 2018, the shaft was found damaged with a hole and exposed wires at tip section, near to tip-shaft transition.Scanning electron microscope analysis showed evidence of mechanical damage, stress marks and a hole on the surface of the tip.This finding has been assessed as a reportable malfunction.

Manufacturer Narrative

It was reported that a patient underwent an atrial fibrillation (afib) procedure with a lasso® nav eco variable catheter and a contraction issue occurred as the loop diameter was not changing normally.The device was visually inspected and the shaft was found damaged with a hole and exposed wires can be seen.Then, deflection and contraction tests were performed and it was found within specifications, the catheter was deflecting correctly.Additionally, a scanning electron microscope (sem) testing was performed on the damaged area and the results showed evidence of mechanical damage, stress marks and a hole on the surface of the tip.The device history record (dhr) was reviewed and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.During manufacturing process, all the catheters are inspected for visual damages before packaging.On line inspections and functional tests are in place to prevent this type of damage from leaving the facility.The customer complaint cannot be confirmed.The root cause of the damage on the tip cannot be determined since there is evidence that the device was manufactured in accordance with documented specification and procedures.Manufacturer's ref.No: (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; 33 technology drive; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: gabriel alfageme ; 33 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 7398279
• MDR Text Key: 104565865
• Report Number: 2029046-2018-01410
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 10846835009637
• UDI-Public: 10846835009637
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K113213
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/16/2018

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: 06/30/2020
• Device Catalogue Number: D134301
• Device Lot Number: 17712577L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/16/2018
• Initial Date FDA Received: 04/04/2018
• Supplement Dates Manufacturer Received: 03/16/2018
• Supplement Dates FDA Received: 07/17/2018
• Date Device Manufactured: 07/27/2017
• 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