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

Catalog Number D134301

Device Problems Device Issue (2379); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/24/2017

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) for the lot number 17696228l has been reviewed and it was verified that the device was manufactured in accordance with documented specifications and procedures.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.(b)(4).

Event Description

It was reported that a patient underwent a paroxysmal atrial fibrillation (afib) procedure with a lasso® nav eco variable catheter.The loop of the lasso® nav eco variable catheter was straightened when it was removed from the sheath.The catheter was replaced and the issue resolved.The procedure was continued.There was no patient consequence reported.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.This initial issue was assessed as not reportable.The overall health risk to the patient was low as the most likely harm was an intra-procedural delay.The biosense webster failure analysis lab received the catheter for assessment on january 25, 2018 and it was noted that the spine of the loop was twisted and sharp edges were formed for electrode # 16 and #17.The twist at the loop was assessed as not reportable as there¿s no indication of wires being exposed.However, the issue of sharp edges at the electrodes was assessed as a reportable malfunction.Therefore, the awareness date for this reportable malfunction is january 25, 2018.

Manufacturer Narrative

Investigation summary: it was reported that a patient underwent a paroxysmal atrial fibrillation (afib) procedure with a lasso® nav eco variable catheter.The loop of the lasso® nav eco variable catheter was straightened when it was removed from the sheath.The catheter was replaced and the issue resolved.The procedure was continued.There was no patient consequence reported.The device was visually inspected and the loop was found twisted with sharp edges on electrodes #16 and #17, then, during the second visual inspection the electrodes were found squashed but with no sharp edges.Then, deflection test was performed and it was found within specifications, the catheter was deflecting correctly.Then, contraction test was performed and the catheter failed.A failure analysis was performed and the catheter handle was opened; the puller wire was found broken inside the tip.Then, the catheter outer diameter was measured and it was found within specification.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 was confirmed.The root cause of the damage on the loop and the puller wire broken inside the tip cannot be determined since there is evidence that the device was manufactured in accordance with documented specification and procedures, it could be related to the manipulation of the device during the procedure, however, this cannot be conclusively determined.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; 33 technology drive; irvine CA 92618
• MDR Report Key: 7286098
• MDR Text Key: 100905213
• Report Number: 2029046-2018-01233
• 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: company representative
• Type of Report: Initial,Followup
• Report Date: 01/25/2018

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: 05/31/2020
• Device Catalogue Number: D134301
• Device Lot Number: 17696228L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2018
• Initial Date Manufacturer Received: 01/25/2018
• Initial Date FDA Received: 02/21/2018
• Supplement Dates Manufacturer Received: 01/25/2018
• Supplement Dates FDA Received: 07/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1