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 Problem Improper or Incorrect Procedure or Method (2017)

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

Event Date 02/03/2017

Event Type  Injury  

Manufacturer Narrative

Event description continuation: navigation catheter was not in close proximity to another catheter.Thermocool smarttouch bi-directional navigation catheter was zeroed after the initial warm-up phase post catheter connection to the carto® 3 patient interface unit.After initial zeroing, force was inaccurate due to zeroing in an area where the catheter was not floating.Force vector was pointing toward the shaft of the catheter and reading contact forces greater than 40 grams.Catheter was re-zeroed in a better location.Carto® 3 system did not indicate to re-zero the catheter.There were no error messages reported on any bwi equipment during the procedure.Since this adverse event required medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious and mdr reportable.Since this event was discovered during the mapping phase, we are taking the conservative approach and reporting this event under both the thermocool smarttouch bi-directional navigation catheter and the lasso navigational variable eco catheter.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 products: acunav catheter, model #: m-5723-09, lot #: qe153112.Webster 4 pole catheter, model #: d-1079-238-s, lot #:17615268m.Non biosense webster, inc.¿ st.Jude medical decapolar livewire.Non biosense webster, inc.- st.Jude medical brk needle.Non biosense webster, inc.- st.Jude medical agilis sheath.(b)(4).

Event Description

It was reported that a (b)(6) female patient underwent an ablation procedure for paroxysmal atrial fibrillation with a thermocool smarttouch bi-directional navigation catheter and lasso navigational variable eco catheter and suffered a cardiac tamponade requiring pericardiocentesis.During mapping phase, the patient became hypotensive and a tamponade was confirmed via intracardiac echocardiogram.Pericardiocentesis yielded 1400ml.Patient was reported to be in stable condition.Patient required 3 days of extended hospitalization as a result of this adverse event for monitoring of the tamponade.Patient fully recovered with no residual effects.There were no factors cited that may have contributed to the adverse event.It was noted that the physician remains uncertain as to when the injury occurred and what caused it.Injury was noticed during mapping phase.Physician¿s opinion regarding the cause of the adverse event is that it was procedure-related.Transseptal puncture was performed with a st.Jude medical brk needle.Sheath in use was a st.Jude medical agilis.Generator was set on power control mode with default cut-off settings.Generator parameters, overall ablation time, and last ablation cycle time at the site of injury were not reported, as no ablation was performed.It was noted that all mapping of the left atrium appeared to be within normal limits.Irrigated catheter flow was set at 2ml/min during mapping.Patient received anticoagulant during the procedure with activated clotting time maintained between 300-350 seconds.There is no information regarding shaft proximity interference (spi) value.Thermocool smarttouch bi-directional.

• 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: 6371092
• MDR Text Key: 68753946
• Report Number: 9673241-2017-00179
• 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
• Report Date: 02/03/2017

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: 08/31/2019
• Device Model Number: D-1343-01-S
• Device Catalogue Number: D134301
• Device Lot Number: 17560144L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/03/2017
• Initial Date FDA Received: 03/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2016
• 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: 61 YR