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 Positioning Problem (3009); Device Handling Problem (3265)

Patient Problems Hemothorax (1896); Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226)

Event Date 09/15/2016

Event Type  Injury  

Manufacturer Narrative

The product was discarded, therefore no product failure analysis can be conducted and device malfunction cannot be confirmed.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.Concomitant medical products: carto 3 system (model# m-4800-01 serial# (b)(4)); c3 ez steer cs with auto id (model# d-1263-07-s lot# 17532490m).(b)(4).Generator parameters, overall ablation time, and last ablation cycle time at the site/time of injury were not reported, as these variables are unknown since the site of injury is unknown.Irrigated catheter flow setting was 8 ml/min less than 30 watts of power and 15 ml/min with greater than 30 watts of power.Patient received anticoagulant during the procedure with activated clotting times maintained between 250-300 seconds.The smarttouch catheter was re-calibrated when the carto displayed an inaccurate force value.A non mdr reportable map shift occurred due to patient movement.There were no other errors reported with bwi equipment during the procedure.Smarttouch was in close proximity to the lasso catheter, as expected with a waca procedure.Smarttouch was zeroed several times after the initial warm-up phase, post-connection to the carto 3 piu.Carto 3 indicated to re-zero the catheter several times.The last calibration was performed towards the end of the procedure in response to an inaccurate force value.Force displayed was noted to be higher than the actual force.

Event Description

It was reported that a 60 year old female patient underwent a pulmonary vein isolation (pvi)/wide area circumferential ablation (waca) procedure for paroxysmal atrial fibrillation with a lasso® 2515 nav eco variable catheter and suffered a cardiac tamponade (requiring pericardiocentesis and surgical intervention) and a pleural effusion (requiring surgical intervention).After the procedure was completed and the catheters were removed, the patient suddenly became hypotensive and a tamponade was confirmed.Pericardiocentesis helped to stabilize the patient.The patient was admitted for further work-up.The patient required extended hospitalization due to the surgical intervention for the tamponade and the hemothorax.The adverse event was considered to be life-threatening immediately after the procedure.There were no factors cited that may have contributed to the adverse event.The left inferior pulmonary vein (lipv) was noted to be difficult to reach, which led the physician to use additional force in order to correctly position the lasso catheter.It was noted that the physician was not certain as to the cause of the adverse event, but that it was not related to any issues with bwi products, but most likely related to the procedure, specifically, the handling of the products.A transseptal puncture was performed with a (b)(4) brk-1 needle ((b)(4)).It was noted that the transseptal puncture was not optimal and the catheters fell out of position several times.This may have led to structural damage while maneuvering back and forth.Sheath used was a (b)(4) agilis nxt 8.5 french.Generator settings included: power control mode with cutoff of 25 watts on the posterior wall and 30 watts on the anterior wall and temperature cut-off of 40°c.The power was not titrated.

• 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: 6014203
• MDR Text Key: 57040361
• Report Number: 9673241-2016-00687
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 09/15/2016

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Model Number: D-1343-01-S
• Device Catalogue Number: D134301
• Device Lot Number: 17532487L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/15/2016
• Initial Date FDA Received: 10/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2016
• 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
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 60 YR
• Patient Weight: 100