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 Problem Difficult To Position (1467)

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

Event Date 12/08/2014

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) procedure with a lasso navigational variable eco catheter and during the bwi failure analysis lab investigation of the returned catheter, it was found that the puller wire was out of the pulley mechanism and may affect the deflection to be stuck.It was reported initially that during the procedure this catheter stopped deflecting.The catheter was not stuck in a partial or fully deflected position.There was no difficulty in removing the catheter from the patient.The st.Jude 8.5fr agilis small curve sheath was used.The catheter was replaced.The procedure continued with no patient consequences.It was assessed as not reportable as the most likely consequence was an intraprocedural delay.The potential risk that it could cause or contribute to a serious injury or death is remote.This event is being reported because the bwi failure analysis lab received the device for evaluation and found during the investigation, the puller wire was out of the pulley mechanism.After further review, this finding was assessed as a reportable issue on may 5, 2015 as this failure may affect the deflection to be stuck.The awareness date for this record is may 5, 2015.

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).

Manufacturer Narrative

(b)(4).It was reported that a patient underwent an atrial fibrillation (afib) procedure with a lasso navigational variable eco catheter and this catheter stopped deflecting.The catheter was replaced and the procedure continued.The procedure was completed without patient consequence.Upon receiving , the catheter was visually inspected and it was found partially deflected.The piston that controls the deflection mechanism of the catheter was activated and it was unable to move.The catheter was tested for deflection and the catheter failed.Then catheter was dissected and it was found that the deflection puller wire came off the pulley and was stuck between the block and pulley causing the catheter to get stuck in a deflected position.The device history record (dhr) was reviewed.The dhr review verifies that the device was manufactured in accordance with documented specification and procedures.The customer complaint has been verified.The investigation showed that the reported condition was unable to reproduced as the no deflection failures were not observed during several deflections cycles.

• 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: shahe garabedian ; 15715 arrow hwy; irwindale, CA 91706 ; 9098397362
• MDR Report Key: 4808238
• MDR Text Key: 5891747
• Report Number: 9673241-2015-00342
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113213
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2017
• Device Model Number: D-1343-02-S
• Device Catalogue Number: D134302
• Device Lot Number: 17080764L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/08/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/26/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1