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

Catalog Number D134301

Device Problems Material Deformation (2976); Sharp Edges (4013)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/26/2018

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.(b)(4).

Event Description

It was reported that a patient underwent an ablation procedure with a lasso® nav eco variable catheter and the ring of a lasso nav catheter became deformed during a procedure.The ring is referred to as being no longer rounded.The catheter was replaced, and the issue was resolved without patient consequence.The response received indicates that the catheter damage resulted in sharp edges and no difficulty occurred while maneuvering the catheter or during the withdrawal.The issue of the ring of a lasso nav catheter becoming sharp is reportable.

Manufacturer Narrative

In the initial report, device code was left blank.The correct device code is sharp edges.Additionally, usage of device was left blank and the correct selection is initial use of the device.Corresponding fields of this report have been updated.Manufacture ref no: (b)(4).

Manufacturer Narrative

It was reported that a patient underwent an ablation procedure with a lasso® nav eco variable catheter and the ring of a lasso nav catheter became deformed during a procedure.Additional information was received (b)(6)2018 indicating the manufacture date: 11/20/2017 and expiration date: 11/19/2020.Corresponding fields of this report have been updated.Upon receipt, the catheter was visually inspected and the loop was found deformed.Deflection and contraction testing was performed.The catheter passed deflection but contraction testing failed.The catheter was observed under the x ray machine and the puller wire was found wrapped around the nitinol.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 the manufacturing process, all 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 has been verified.The root cause of the puller wire around the nitinol cannot be determined since there is evidence that the device was manufactured in accordance with documented specification and procedures.Manufacturer 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
• MDR Report Key: 7737904
• MDR Text Key: 115793938
• Report Number: 2029046-2018-01870
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 10846835009637
• UDI-Public: 10846835009637
• Combination Product (y/n): N
• PMA/PMN Number: K113213
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup,Followup
• Report Date: 07/02/2018

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: 11/19/2020
• Device Catalogue Number: D134301
• Device Lot Number: 17763070L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2018
• Initial Date Manufacturer Received: 07/02/2018
• Initial Date FDA Received: 07/31/2018
• Supplement Dates Manufacturer Received: 07/02/2018; 08/11/2018
• Supplement Dates FDA Received: 08/01/2018; 09/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1