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 Difficult To Position (1467); Material Separation (1562)

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

Event Date 02/20/2014

Event Type  malfunction  

Event Description

It was reported that during this procedure the lasso navigational variable eco catheter was placed in the left atrium and was guided via vdrive / vloop by stereotaxis as they were going to map the left atrium.This part of the procedure went well.However, when the physician tried to again reach the right pulmonary veins to check for the block after he had ablated, the deflection mechanism of the catheter stopped working.The catheter was straight and could not be deflected.The catheter was replaced.There was a 10 minute delay.After, all veins could be reached.The procedure was successful.There was no patient injury reported.The complaint reported was not indicative of a reportable event.Upon visual inspection of the returned complaint catheter on (b)(6) 2014, the bwi failure analysis lab noted that the transition separated between the shaft and the tip lumen.This condition was not reported by the customer.Upon request, additional information was provided on this returned catheter condition.This defect was not noticed.Initially the catheter was working properly.The physician only checked the deflection mechanism of the catheter, since during the procedure the loop did not work properly.The returned catheter condition is indicative of a reportable event, thus marking (b)(6) 2014 as the awareness date for this report.

Manufacturer Narrative

Investigation still in progress.A supplemental report or device evaluation will be submitted.The reported lot number was provided as 15999288l.(b)(4).

Manufacturer Narrative

(b)(4) it was reported that during this procedure the lasso navigational variable eco catheter was placed in the left atrium and was guided via vdrive / vloop by stereotaxis as they were going to map the left atrium.This part of the procedure went well.However, when the physician tried to again reach the right pulmonary veins to check for the block after he had ablated, the deflection mechanism of the catheter stopped working.The catheter was straight and could not be deflected.The catheter was replaced.There was a 10 minute delay.After, all veins could be reached.The procedure was successful.There was no patient injury reported.The returned device was visually inspected upon receipt and the tip and shaft were found separated.This condition was not reported by the customer.Further investigation revealed that the cause of the failure was the separation of the polyimide stiffener from the quad lumen tip.However, and after an investigation carried out with the manufacturing and the production teams, the root cause of the polyimide slippage could not be determined.An internal corrective action has been opened to investigate the tip ¿ shaft separation issue.Then per the reported event, the catheter was tested for deflection and contraction and the catheter failed deflection.Afterwards, the catheter was dissected and it was noticed that the t bar slid down from its place.The device history record (dhr) was reviewed and no anomalies were found related to this failure mode.Dhr review verifies that the device was manufactured in accordance with documented specification and procedures.In addition, all the catheters are inspected 100% before packaging.On line inspections are in place to prevent this type of defect from leaving the facility.The reported customer complaint has been verified.An internal corrective action has been opened to investigate the tip ¿ shaft separation issue and the t bar issue.

• 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: jaime chavez ; 15715 arrow highway; irwindale, CA 91706 ; 9098398483
• MDR Report Key: 3781162
• MDR Text Key: 15327729
• Report Number: 9673241-2014-00167
• 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: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: D-1343-02-S
• Device Catalogue Number: D134302
• Device Lot Number: UNKNOWN_D-1343-02-S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2014
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/20/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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