MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (JUAREZ) LASSO® 2515 NAV ECO VARIABLE CATHETER; CATHETER, ELECTRODE RECORDING OR PROBE, ELECTRODE RECORDING

Model Number D-1343-01-S

Device Problem Device Inoperable (1663)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/03/2015

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 a procedure with a lasso navigational variable eco catheter.Initially, the puller wire was not working properly.Deflecting was hampered.The curve of the catheter was not stuck in a deflected position.There was no difficulty in removing the catheter.There was no ring or physical damage observed at the distal end of the catheter.The procedure was completed with no patient consequence.This issue was assessed as not reportable as 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 failure analysis lab discovered during the visual inspection of the returned catheter on december 14, 2015 that the spine cover was scratched with a piece of spine cover torn off leaving braid metal exposed about 3.5mm from the proximal end of ring #20.The lasso loop was returned in a contracted position with a deformed shaped.However, the contraction was not stuck in this position.Additional information was received on this returned catheter condition stating that they did not notice the returned catheter condition.It was confirmed that there was no patient consequence.Since the braid metal was exposed to the patient, the catheter integrity was not maintained.This returned catheter condition was assessed as a reportable malfunction.The awareness date was reset to december 14, 2015.

Manufacturer Narrative

(b)(4).It was reported that a patient underwent a procedure with a lasso navigational variable eco catheter.The puller wire was not working properly.Deflecting was hampered.The curve of the catheter was not stuck in a deflected position.There was no difficulty in removing the catheter.There was no ring or physical damage observed at the distal end of the catheter.The procedure was completed with no patient consequence.Upon receipt, the catheter was visually inspected and the lasso loop returned had a deformed shaped.The spine cover was found scratched and torn with the braid exposed.During a second visual inspection under a microscope reddish material was observed at the area.Further information received indicates that this condition was not noticed by the customer.A scanning electron microscope (sem) testing was performed at the area and results show that the external surfaces of the spine cover exhibit evidence of scratches and rupture induced by an unknown object.Deflection and contraction tests were performed and the catheter passed deflection but contraction failed.An x-ray of the catheter was taken and it was found that the puller wire was wrapped around the nitinol causing the contraction issue.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.The customer complaint has been verified.Based on available analysis results, it could not be identified whether the issue is related to an internal or an external cause.

• Brand Name: LASSO® 2515 NAV ECO VARIABLE CATHETER
• Type of Device: CATHETER, ELECTRODE RECORDING OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BIOSENSE WEBSTER, INC. (JUAREZ); circuito interior norte #1820; parque industrial salvacar; juarez, chihuahua 32599 ; MX 32599
• Manufacturer (Section G): BIOSENSE WEBSTER, INC. (JUAREZ); circuito interior norte #1820; parque industrial salvacar; juarez, chihuahua 32599 ; MX 32599
• Manufacturer Contact: joaquin kurz ; 9497893837
• MDR Report Key: 5365233
• MDR Text Key: 36288299
• Report Number: 9673241-2016-00021
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 11/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2018
• Device Model Number: D-1343-01-S
• Device Catalogue Number: D134301
• Device Lot Number: 17308075L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/05/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/27/2015
• 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