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 Dent in Material (2526); Device Displays Incorrect Message (2591); Wrinkled (2614)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/29/2016

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 magnetic sensor error displayed on the carto 3 system.The catheter cable was replaced and the issue remained.The catheter was replaced and the issue resolved.The procedure was completed with no patient consequence.This event was originally assessed as not mdr reportable because the incidence of magnetic sensor error is easy detectable by the user.The catheter is inoperable, since it cannot be visualized on the carto 3 system.The user will have to replace the catheter.The potential risk that it could cause or contribute to a serious injury or death is remote.The device was returned to biosense webster failure analysis lab and on august 26, 2016 it was discovered that ring #19 has a dent, is rough, and has some type of white material underneath it on the distal side.In addition, ring #20's spine cover is wrinkled on the proximal side in two places.There was no difficulty withdrawing the catheter through the baylis torflex 45 8.5 french sheath that may have caused this.The returned catheter condition was not noticed prior to use of the catheter, upon withdrawal or prior to sending the catheter back for analysis.The issue with the spine cover is not mdr reportable since the catheter integrity is maintained and no internal components are exposed to patient, the potential risk that it could cause or contribute to a serious injury or death is remote.However, the finding of the dented ring is mdr reportable because if electrodes of the catheter are dented, squashed or lifted, then there is potential risk to the patient.In addition, the issue with white material is also mdr reportable because if material that does not belong to the catheter is stuck underneath the electrodes, then it can cause embolism or stroke.The awareness date has been reset to the date of the reportable lab finding august 26, 2016.

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 magnetic sensor error displayed on the carto 3 system.Upon receipt, the catheter was visually inspected catheter electrode #19 was found dent and rough with a white foreign material underneath, which is why this complaint was reported to the fda.A fourier transforms infrared spectroscopy (ft-ir) was performed in order to identify the type of foreign material under the electrode; the results demonstrated that particle was mainly composed of a styrene based material, the most likely of which is acrylonitrile butadiene styrene.The catheter outer diameters were measured and were found within specifications.Further information received indicates that this condition was not noticed prior to sending the catheter back.It might happen while sending the catheter back to bwi for analysis.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.Additionally wrinkles were observed at catheter lasso spine cover; however during the analysis it was determined that this condition is acceptable during the manufacturing process.The catheter was evaluated for eeprom, carto 3 and sensor functionality.The catheter was recognized by carto 3 system, no error messages were displayed and the catheter was properly visualized.Eeprom data demonstrates the catheter was properly calibrated during manufacturing.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 sensor error cannot be confirmed.Regarding the electrode damage, based on available analysis finding results, the failure mode does not appear to be caused by any internal bwi processes since all catheters are visually inspected.

• 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: 5971319
• MDR Text Key: 55725873
• Report Number: 9673241-2016-00613
• 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: 07/29/2016

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: 05/31/2019
• Device Model Number: D-1343-01-S
• Device Catalogue Number: D134301
• Device Lot Number: 17481747L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/29/2016
• Initial Date FDA Received: 09/22/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/11/2016
• 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