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 No Display/Image (1183); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/11/2017

Event Type  malfunction  

Manufacturer Narrative

No device was received for analysis at the time of submission of the initial 3500a.Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.The device history record (dhr) for the lot number 17614681l has been reviewed and it was verified that the device was manufactured in accordance with documented specifications and procedures.Concomitant product: carto 3 system, model #: fg-5400-00k, serial #: (b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) procedure with a lasso navigational variable eco catheter.Before the procedure, the image was not displayed at the monitor of the physician¿s side.When the dvi cable was connected, the image displayed.The issue was resolved by changing the dvi cable to back-up one.After the lasso navigational variable eco catheter was inserted into the left atrium.Then the catheter was placed into the pulmonary vein.After 3 hours of using this catheter, the ring diameter was minimized and used, the ring shape began to distort.The catheter was removed from the patient¿s body.They tried to adjust the ring, but the shape of the ring was distorted.The issue was resolved by changing the catheter to another one.The procedure was completed with no patient consequence.Additional information was received stating that the loop of the catheter was jammed in a fully contracted position.There was no difficulty in turning or pushing the handle.There was no difficulty in removing the catheter.The visualization issue was assessed as not reportable as the most likely consequence was an intraprocedural delay.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, was remote.The loop being stuck in a contracted position issue was assessed as a reportable malfunction.This issue could potentially cause vessel or cardiac structure damage if the physician introduces the loop into the ventricles by mistake.

Manufacturer Narrative

The bwi failure analysis lab received the device for evaluation on 6/13/2017.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

Manufacturer's ref.No: (b)(4).It was reported that a patient underwent an atrial fibrillation (afib) procedure with a lasso navigational variable eco catheter.The lasso navigational variable eco catheter was inserted into the left atrium.Then the catheter was placed into the pulmonary vein.After 3 hours of using this catheter, the ring diameter was minimized and used, the ring shape began to distort.The catheter was removed from the patient¿s body.They tried to adjust the ring, but the shape of the ring was distorted.The issue was resolved by changing the catheter to another one.The procedure was completed with no patient consequence.Additional information was received stating that the loop of the catheter was jammed in a fully contracted position.There was no difficulty in turning or pushing the handle.There was no difficulty in removing the catheter.Upon receipt, the catheter was visually inspected and it was found in normal conditions.Then per the event, deflection and contraction tests were performed and the catheter passed deflection but contraction failed.An x ray of the catheter loop was taken and the puller wire was found wrapped around the nitinol.During the manufacturing process, all pieces are tested and inspected in order to prevent this type of defect before leaving the facility.The device history record (dhr) was reviewed and no anomalies were found.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.The customer complaint has been verified.The root cause of the catheter contraction failed cannot be determined since there was evidence of the proper manufacturing assembly.The instructions for use (ifu) states to avoid potential damage to anatomical structures, do not attempt to pull the catheter or withdraw it into the sheath with the loop in a contracted position.The loop should be fully relaxed (handle grip rotated fully to the left) to minimize tension applied to the nitinol structure.

• 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 ; 33 technology drive; irvine, CA 92618 ; 9497893837
• MDR Report Key: 6619010
• MDR Text Key: 77376945
• Report Number: 9673241-2017-00443
• 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: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Model Number: D-1343-01-S
• Device Catalogue Number: D134301
• Device Lot Number: 17614681L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/11/2017
• Initial Date FDA Received: 06/07/2017
• Supplement Dates Manufacturer Received: Not provided; 05/11/2017
• Supplement Dates FDA Received: 06/20/2017; 07/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/18/2016
• 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