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 Device Operates Differently Than Expected (2913); Scratched Material (3020)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/05/2016

Event Type  malfunction  

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

It was reported that a patient underwent an atrial fibrillation procedure with a lasso nav variable eco catheter and a contraction issue occurred.The loop of the catheter could not be contracted as intended when the catheter was controlled inside the left atrium.The catheter was removed from the cardiac cavity and was confirmed that the catheter could not be contracted.The knob was able to be turned and pushed down.The issue was resolved by changing the catheter to another one.The procedure was completed with no patient consequence.This event was originally assessed as not mdr reportable because the potential risk that it could cause or contribute to a serious injury or death is remote.On october 28, 2016, the biosense webster inc.Failure analysis lab discovered ring #20 is slightly squashed with the distal side damaged and sharp with white/light blue material underneath it.There was no difficulty withdrawing the catheter that may have caused this damage.This condition was not noted prior to use, upon withdrawal or prior to sending the catheter back for analysis.This finding is mdr reportable because the damage to the electrode has created a sharp edge which is a potential harm to the patient such as laceration.The issue with the white/blue material is also reportable because if material that does not belong to the catheter is stuck underneath the electrodes, then it could cause embolism or stroke.The awareness date for this record is october 28, 2016, the date the reportable lab finding was discovered.

Manufacturer Narrative

Manufacturer's ref.No: (b)(4).It was reported that a patient underwent an atrial fibrillation procedure with a lasso nav variable eco catheter and a contraction issue occurred.The loop of the catheter could not be contracted as intended when the catheter was controlled inside the left atrium.The returned device was visually inspected and the rings #1 and #20 were found slightly squashed and sharp at distal side; and white-light blue material was found underneath the ring #20, which is why this complaint was mdr reportable.The catheter ods were measured and all were found within specifications.Therefore, a fourier transforms infrared spectroscopy test (ft-ir) was performed in order to identify the type of foreign material; the results demonstrated that the material is presumably composed of abs plastic (acrylonitrile butadiene styrene-based).Then per the event, a deflection and contraction tests were performed and the catheter passed deflection but contraction did fail.The catheter was dissected and the puller wire was found broken in the tip section.Scanning electron microscope analysis was performed to identify the root cause of the puller wire broken; the results showed that there was evidence of elongation and ductile dimples.It was concluded that the process objective evidence demonstrated that the unit was processed and accepted according to the manufacturing process and the issue could be related to excessive force applied while activating the contraction mechanism.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 has been confirmed.Based on the available analysis finding results; the puller wire broken does not appear to be caused by any internal bwi processes.On other hand, the root cause of the electrode damage cannot be determined.

• 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: 6119555
• MDR Text Key: 60907163
• Report Number: 9673241-2016-00814
• 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
• Report Date: 10/05/2016

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: 06/30/2019
• Device Model Number: D-1343-01-S
• Device Catalogue Number: D134301
• Device Lot Number: 17514520L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/05/2016
• Initial Date FDA Received: 11/21/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/16/2016
• 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