MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (JUAREZ) LASSO® 2515 NAV ECO VARIABLE CATHETER; CATHETER, ELECTRODE RECORDING OR PROBE, ELECTRODE RECORDING

Model Number D-1343-02-S

Device Problems Break (1069); Unable to Obtain Readings (1516); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/02/2015

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.As such, the investigation will be closed.If the complaint device is received in the future we will reopen the complaint and perform the investigation as appropriate.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.Due to the august 2015 fda maintenance where the 3500a codes were updated, the 3500a codes will be added until the biosense webster system is also updated.(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 broken tip occurred.A magnetic sensor error was seen on the carto 3 system and the 10 pole lasso nav catheter would not map.The physician went to exchange the catheter and the tip of the catheter bent back on itself and could not be withdrawn through the sheath.The physician had to withdraw the sheath and catheter as a unit to prevent dislodgement of the damaged catheter tip.The sheath was transseptal and had to be replaced as a result.The procedure was continued and there was no patient consequence.This event was conservatively assessed as a reportable event due to the physician's assessment that there was risk of catheter tip dislodgement due to the damage incurred.

Manufacturer Narrative

The bwi failure analysis lab received the device for evaluation on 10/07/15.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

(b)(4).It was reported that a patient underwent an atrial fibrillation procedure with a lasso® 2515 nav eco variable catheter and a broken tip occurred.Catheter was inspected upon received and it was noticed that the catheter lasso loop was bent and was stuck in the tip section of the sheath.Loop was found in contracted position on the proximal side of electrode #9.Per the visual condition and event reported, catheter ods were measured and all were found within specifications.Catheter was inserted on the returned sheath and no resistance was experienced; however due to the catheter condition resistance was notice while withdrawing the catheter.Due to damage catheter failed contraction test.Further information received indicates that there was no anatomical peculiarity that might contributed to the catheter damage.Instructions for use clearly states to not use excessive force to advance or withdraw the catheter through the guiding sheath, when resistance is encountered.In addition, extra care should be taken while inserting, aspirating and manipulating the guiding sheath.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.Per the magnetic sensor error reported, the catheter was evaluated for eeprom, and the functionality of the catheter sensor was tested on the carto 3 system.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 magnetic sensor error reported by the customer cannot be confirmed.The cause of the catheter condition is unknown; however does not appeared to be manufacturing related.

• 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 ; 9497893837
• MDR Report Key: 5106195
• MDR Text Key: 26966965
• Report Number: 9673241-2015-00682
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• 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: Followup
• Report Date: 09/02/2015

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: 01/31/2017
• Device Model Number: D-1343-02-S
• Device Catalogue Number: D134302
• Device Lot Number: 16050549L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/25/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/27/2014
• 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