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 Difficult to Remove (1528); Malposition of Device (2616); Scratched Material (3020)

Patient Problems Mitral Insufficiency (1963); Mitral Regurgitation (1964); Rupture (2208); Mitral Perforation (2512)

Event Date 09/09/2015

Event Type  Injury  

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.Concomitant products: 1.Carto 3 system, model #: m-4800-01, serial #: (b)(4).2.Stockert 70 system, model #: m-5463-01, serial #: (b)(4).3.Cool flow pump, model #: m-5491-02, serial #:(b)(4).Ez steer thermocool sf navigational catheter, model #: d-1313-04-s, lot #: 17266814l.(b)(4).Event description continuation: the biosense webster failure analysis lab received the catheter and noted that the electrode ring #4 was damaged and sharp edges were formed.Foreign material was also found on electrode ring #4.The spine cover between electrode ring #4 and #5 was damaged as the spine cover at the loop was twisted.Additional information was received stating that the electrode ring #4 damage was noticed on the carto system (black electrode) during the removal of catheter.This was not present during the fast anatomical mapping of the left atrium.The damage was only noticed during the removal of the catheter by advancing the sheath over the catheter in the attempt of freeing the catheter from the mitral valve.The damage might have occurred as the sheath was being repeatedly advanced over the catheter in the attempts and successful removal of the catheter from the mitral valve leaflet.The biosense webster representative and the physician did not visually inspect the lasso navigational variable eco catheter after it had been removed from the patient.The issue of the spine cover at the loop was twisted was assessed as not reportable as the potential that it could cause or contribute to a death or serious injury, or other significant adverse event was remote.The issue of the electrode ring #4 had sharp edges with foreign material was assessed as a reportable malfunction.The sharp edges may cause damage to vascular endothelial linings during the withdrawal of the catheter and sheath.In addition, dislodgement of the foreign material inside the patient poses a risk of embolus.

Event Description

It was reported that a (b)(6) male patient underwent an atrial fibrillation (afib) procedure with a lasso navigational variable eco catheter and suffered a cardiac valve rupture and mitral insufficiency which did not require surgical intervention.The patient's medical history is unknown.Also, the biosense webster failure analysis lab noted the returned catheter condition of electrode ring #4 had sharp edges with foreign material.During the fast anatomical mapping of the left atrium, the catheter "flipped" into the left ventricle.When pulling the catheter back into the left atrium, there was resistance and the catheter appeared to be "caught" on something and it's appearance was "springy" like a spring coil was being stretched.A perforation of the mitral valve leaflet was noticed as the catheter was displayed stuck in the mitral valve.The catheter was removed from the leaflet of the mitral valve with manipulation of the st.Jude medical 8.5 french agilis sheath and the catheter with the guidance of transesophageal echocardiogram.The patient incurred mitral valve regurgitation as a result.No medical intervention was administered to the patient.The patient was reported to be in stable condition.The ez steer thermocool sf navigational catheter never entered the patient's body.The echo performed the next morning showed less mitral valve regurgitation than at the time of the incidence.The patient was discharged the following day.The physician's opinion regarding this event was that it was product and procedure related.The event is reportable as a serious injury.

Manufacturer Narrative

(b)(4) it was reported that a (b)(6) male patient underwent an atrial fibrillation (afib) procedure with a lasso navigational variable eco catheter and suffered a cardiac valve rupture and mitral insufficiency.During the fast anatomical mapping of the left atrium, the catheter "flipped" into the left ventricle.When pulling the catheter back into the left atrium, there was resistance and the catheter appeared to be "caught" on something and it's appearance was "springy" like a spring coil was being stretched.A perforation of the mitral valve leaflet was noticed as the catheter was displayed stuck in the mitral valve.The catheter was removed from the leaflet of the mitral valve with manipulation of the st.Jude medical 8.5 french agilis sheath and the catheter with the guidance of transesophageal echocardiogram.The patient incurred mitral valve regurgitation as a result.No medical intervention was administered to the patient.The patient was reported to be in stable condition.The echo performed the next morning showed less mitral valve regurgitation than at the time of the incidence.The patient was discharged the following day.Upon receipt, the catheter was visually inspected and ring #4 was found damaged with sharp edges and a foreign material underneath.Spine cover between ring #4 and #5 was damaged and loop twisted.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.Due to the foreign material observed a ft-ir test was performed in order to identify the type of foreign material.The results demonstrated that the particle had a biological composition similar to that showed by human tissue.Further information received indicates that the damages observed were noticed during the removal of the catheter and that might been done during the attempts of the catheter removal.A scanning electron microscope (sem) confirmed that the twisted sections present evidence of plastic deformation and scratched marks caused by an unknown device as well as mechanical damage.The instructions for use (ifu) 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 returned device was then evaluated for electrical resistance and current leakage and it failed on electrode # 1, #3 and #4.Further examination revealed that the lead wires were broken due to the lasso damage.The deflection and contraction tests were performed and the catheter passed.The catheter was evaluated for eeprom, and the functionality of the sensor catheter was tested on carto system.Eeprom data demonstrates the catheter was properly calibrated during manufacturing.The catheter was recognized by carto 3 system, however error 116 was displayed.The catheter was then dissected and it was determined that the root cause was an internal failure of the sensor.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 cause of the catheter entrapment and mitral perforation is unknown.However, it does not appear 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: 5136337
• MDR Text Key: 27844194
• Report Number: 9673241-2015-00715
• 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: Followup
• Report Date: 09/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2018
• Device Model Number: D-1343-02-S
• Device Catalogue Number: D134302
• Device Lot Number: 17266675L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/08/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/05/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/24/2015
• 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
• Patient Outcome(s): Other
• Patient Age: 62 YR
• Patient Weight: 136