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 Problems Image Display Error/Artifact (1304); Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/09/2015

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) procedure with a lasso nav variable eco catheter, and a visualization issue and noise occurred.Electrodes 13, 19, and 20 displayed black on the carto 3 system.In addition, there was noise from the electrodes that were being displayed on the carto 3 system and on the recording system.The catheter was replaced and the issue resolved.There was no patient consequence.This event was assessed as not reportable since these issues are highly detectable and posed low risk to the patient.When the product was received for analysis in the biosense webster (bwi) failure analysis lab, it was discovered that ring #13 was damaged.There was an opening found under ring #13 where internal wires could be seen when the catheter is bent.The spine cover was also twisted between ring #12 and ring #13.Upon request additional information was received on the returned catheter condition.The catheter looked normal upon insertion, as the physician made no mention of anything unusual.The physician decided to withdraw the catheter to replace it to resolve the noise issue and there was some difficulty in withdrawing the catheter into the sheath.The catheter was outside the right superior pulmonary vein, so no anatomical structures are there that the catheter could have become intertwined with.With a little extra force, the catheter was pulled back in to the sheath and then was removed smoothly from the patient.An 8.5fr agilis sheath was used for the lasso.The catheter was replaced and the afib ablation was successfully completed.The exposed wires at electrode 13 were noticed upon removal of the catheter.

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 continuation: this finding is indicative of a reportable event because the exposed internal wires pose a risk to the patient.The awareness date for this record is (b)(6) 2015 because this is the date the product was received at bwi.After this date is when confirmation was received from the bwi representative that the condition was noticed prior to sending the catheter back.

Manufacturer Narrative

(b)(4) it was reported that a patient underwent an atrial fibrillation (afib) procedure with a lasso nav variable eco catheter, and a visualization issue and noise occurred.The returned device was visually inspected upon receipt and it was found that the spine cover was twisted.Ring #13 was damaged with an opening and internal wires exposed which was why this complaint was reported to the fda.Further information received indicates that the exposed wires were noticed upon removal of the catheter.The received information also mentioned that there was some difficulty while withdrawing the catheter into the sheath when the noise was seen this might have contributed to the catheter damage.The catheter outer diameters were measured and it was found within specifications.The returned device was then evaluated for electrical resistance and current leakage and it failed on electrodes #13, #19 and #20.Further examination revealed that the lead wires for electrodes #13, #19 and #20 were broken causing the improper signal condition.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 regarding a visualization issue has been verified.

• 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: 4751873
• MDR Text Key: 5888927
• Report Number: 9673241-2015-00265
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/09/2015

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: 11/30/2017
• Device Model Number: D-1343-01-S
• Device Catalogue Number: D134301
• Device Lot Number: 17147289L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/09/2015
• Initial Date FDA Received: 05/06/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/14/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/07/2014
• 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