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 Break (1069); No Display/Image (1183); Device Displays Incorrect Message (2591); Wrinkled (2614)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/22/2016

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® 2515 nav eco variable catheter and a contraction issue occurred.The first lasso catheter was not displayed on the carto 3 system when the catheter was inserted into the patient¿s body and a sensor error was displayed.The cable was changed but the issue continued.The issue was resolved by changing the catheter.After replacing the catheter, the second lasso catheter ring could not be contracted.The issue was resolved by again changing the catheter to another one.The procedure was completed with no patient consequence.These issues were 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 september 30, 2016, the biosense webster failure analysis lab discovered that the second lasso catheter ring #7 and #8 were damaged and lifted with spine wrinkles and stretched.In addition, the spine cover was twisted and wrinkled between ring #19 and #20 down to the transition with the peek housing.This condition was not noticed prior to use or before sending the catheter back for analysis.These findings have been assessed as mdr reportable because if the electrodes of the catheter are dented, squashed, lifted, then ring edges may be sharp and there is potential harm to the patient.The awareness date has been reset to september 30, 2016, the date the reportable damage was discovered.

Manufacturer Narrative

(b)(4).It was reported that a patient underwent an atrial fibrillation procedure with a lasso® 2515 nav eco variable catheter and a contraction issue occurred as the lasso catheter ring could not be contracted.The returned device was visually inspected upon receipt and the spine cover was found twisted and wrinkled.Electrodes were found damaged which is why this complaint was mdr reportable.Per this condition the catheter outer diameters were measured and were found within specifications.During the manufacturing process all the catheters are inspected for visual damages before packaging.On line inspections are in place to prevent this type of damage from leaving the facility.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 catheter was evaluated for deflection and contraction test.Catheter passed deflection test, however failed during contraction test.According to the analysis results contraction issue might be related to the loop damaged observed.Due to the physical force applied to the spine cover this part of the catheter was found stretched and full contraction cannot be done; however this cannot be conclusively determined.The customer complaint has been verified.Based on available analysis finding a result, the failure mode does not appear to be caused by any internal bwi processes, since there was evidence of a proper manufacturing process as well as on line inspection and contraction test are performed to detect this type of defects.

• 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: 6055632
• MDR Text Key: 58824128
• Report Number: 9673241-2016-00736
• 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: 08/23/2016

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: 03/31/2019
• Device Model Number: D-1343-01-S
• Device Catalogue Number: D134301
• Device Lot Number: 17459686L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/22/2016
• Initial Date FDA Received: 10/25/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/23/2016
• 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