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 Entrapment of Device (1212); Hole In Material (1293); Mechanical Jam (2983); Scratched Material (3020); Noise, Audible (3273)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/25/2017

Event Type  malfunction  

Manufacturer Narrative

Event description continuation: the risk to the patient could have been critical due to the potential of thrombus formation from exposure to internal parts of the catheter.Therefore this finding is mdr reportable.The awareness date has been reset to february 28, 2017.The date the reportable damage was discovered.Manufacturer's ref.No: (b)(4).The returned device was visually inspected and a hole was observed in the spine cover at the tip area, leaving internal components exposed and reddish material was observed in the damage.Per this condition, a scanning electron microscope (sem) testing was performed over the damaged area; the results showed evidence of elongations and a rupture on the surface of the spine cover.It is possible that damage was generated due to stress and/or excessive manipulation.Per event reported, the catheter was evaluated for electrical resistance and current leakage and it failed on 12 electrodes.Further examination revealed that the 12 lead wires were found broken causing the improper signal condition.As well, reddish material was observed in the internal components causing the current leakage failure.Furthermore, the catheter was evaluated for eeprom, carto 3 system and sensor functionality.The catheter was recognized by carto 3 system, no error messages were displayed and the catheter was properly visualized.In addition, eeprom data demonstrates the catheter was properly calibrated during manufacturing.During manufacturing process all pieces are tested and inspected in order to prevent this type of defect before to leave 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 wires breakage cannot be determined.Regarding the damage found in the tip; 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.

Event Description

It was reported that a patient underwent an ablation procedure for atrial fibrillation with a lasso® 2515 nav eco variable catheter and suffered a medical device entrapment and signal noise.When the lasso nav variable eco catheter was placed at the superior vena cava (svc), the loop of the catheter became stuck.Electrical potentials displayed normally.When the catheter was placed in the right superior pulmonary vein (rspv), a signal noise occurred affecting the carto.Physician had a signal available to monitor via the body surface electrocardiograms.There was no medical or surgical intervention reported.The issue was resolved by exchanging the catheter.Procedure was completed without incidence.The catheter was withdrawn without difficulty.There were no patient consequences during or post-procedure.This event was originally assessed as not mdr reportable because since there were no patient or user consequences and there was an available signal to monitor the patient¿s heart rhythm, therefore the risk to the patient is low.The device was returned to the biosense webster failure analysis lab and on (b)(6) 2017, it was discovered that there was a hole observed in the spine cover between the ring #20 and ring #21.The braid wire was exposed in the hole of spine cover.Reddish brown material was also observed in the hole section.There was no difficulty withdrawing the catheter from the patient that may have cause this damage.In addition, this damage was not noticed prior to use, upon withdrawal or prior to sending the catheter back for analysis.The presence of reddish brown material is not reportable as this is an expected finding after these procedures.The hole in the catheter covering has created a break in catheter integrity, causing an internal catheter component to be exposed.

• 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: 6427722
• MDR Text Key: 71065207
• Report Number: 9673241-2017-00236
• 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
• Report Date: 01/26/2017

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: 08/31/2017
• Device Model Number: D-1343-01-S
• Device Catalogue Number: D134301
• Device Lot Number: 17559426L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/25/2017
• Initial Date FDA Received: 03/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/03/2016
• 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