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

Catalog Number D134301

Device Problem Sharp Edges (4013)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/25/2018

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.The device history record (dhr) for the lot number 30071287l has been reviewed and it was verified that the device was manufactured in accordance with documented specifications and procedures.Manufacturer's reference number:(b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) procedure with a lasso® nav eco variable catheter.During the procedure, the catheter puller wire lost deflection.The catheter was replaced and the issue resolved.The procedure continued with no patient consequence.This deflection issue was assessed as not reportable.Since the catheter was unable to deflect, the user will not be able to use the device and will have to replace it.The most likely consequence was an intraprocedural delay.The potential risk that it could cause or contribute to a serious injury or death was remote.The biosense webster product analysis lab received the device for evaluation and discovered on (b)(6) 2018 that ring #20 was lifted.On (b)(6) 2018, during additional assessment, the lifted ring was also found to be rough.Therefore, on (b)(6) 2018, a scanning electron microscope (sem) was performed and it shows the ring is lifted and folded.There is evidence of mechanical damage, stress marks and a sharp edge was observed.It is possible that the damage was generated with an unknown object.No other anomalies were observed.The returned condition of the ring lifted and rough/sharp was assessed as a reportable issue.The awareness date for this reportable finding is (b)(6) 2018.

Manufacturer Narrative

Investigation summary: it was reported that a patient underwent an atrial fibrillation (afib) procedure with a lasso® nav eco variable catheter.During the procedure, the catheter puller wire lost deflection.The catheter was replaced and the issue resolved.The procedure continued with no patient consequence.The device was inspected and ring 20 was found lifted and rough.Then, the deflection test was performed and the catheter failed.A failure analysis was performed and the catheter was observed under the x ray machine and the t bar was found slid down causing the improper deflection condition.The contraction test was performed and the catheter passed.The outer diameter was measured and it failed due to the damage observed.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 sharp edge was observed.It is possible that the damage was generated with an unknown object.No other anomalies were observed.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 t bar slippage and the electrode damage 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 handling of the device, 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: 8205403
• MDR Text Key: 131771240
• Report Number: 2029046-2018-02499
• 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: 10/25/2018

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: No Information
• Device Expiration Date: 06/26/2021
• Device Catalogue Number: D134301
• Device Lot Number: 30071287L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2018
• Initial Date Manufacturer Received: 12/03/2018
• Initial Date FDA Received: 12/30/2018
• Supplement Dates Manufacturer Received: 12/21/2018
• Supplement Dates FDA Received: 01/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1