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

Model Number D-1343-02-S

Device Problems Malposition of Device (2616); Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/08/2015

Event Type  malfunction  

Manufacturer Narrative

The suspected device is the aforementioned lasso catheter.However, the original event reported to bwi was for a smarttouch catheter (lot # unk).We believe this was an error in the original report.If additional information is received to indicate otherwise, a supplemental mdr report will be submitted for this issue.(b)(4) the bwi failure analysis lab received the device for evaluation.Visual inspection was performed and spine cover has large wrinkle on proximal side of ring #20.The catheter passed contraction test but fail deflection test.It was found that the deflection puller wire was found out of the pulley.The device history record (dhr) lot 17096427l 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.Complaint was confirmed.

Event Description

It was reported that a patient underwent a procedure with a lasso 2515 nav eco variable catheter and the device could not be deflected during mapping the left atrium.The procedure was completed successfully with a similar device and no patient consequence.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.On (b)(6) 2015 bwi failure analysis laboratory found that catheter was stuck in a deflected position.Therefore, this case has been reassessed as mdr reportable since the curve is stuck in deflected position on curved tip and cannot be relaxed.This could potentially contribute to an adverse event during forceful withdrawal.

• 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 3259 9; MX 32599
• Manufacturer Contact: shahe garabedian ; 9098397362
• MDR Report Key: 4904016
• MDR Text Key: 24151907
• Report Number: 9673241-2015-00434
• Device Sequence Number: 1
• Product Code: DRF
• 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: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/11/2015

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: 08/31/2017
• Device Model Number: D-1343-02-S
• Device Catalogue Number: D134302
• Device Lot Number: 17096427L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/08/2015
• Initial Date FDA Received: 07/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/18/2014
• 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