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 Advance (2920); Positioning Problem (3009)

Patient Problem Cardiac Tamponade (2226)

Event Date 01/19/2016

Event Type  Injury  

Manufacturer Narrative

The product was discarded, therefore no product failure analysis can be conducted and device malfunction cannot be confirmed.Since no lot number was provided, no device history record (dhr) review could be performed.Concomitant products: carto 3 system.(b)(4) are related to the same incident.Event description continuation: surgical pericardial drainage was performed and the patient was then stable and recovering from surgery.The patient did require extended hospitalization for surgery recovery.Additional information was received on the event.The patients anatomy of a rotated heart, might have contributed to the event.There were no error messages observed on biosense webster equipment during the procedure.The patient¿s condition has since improved.The physician¿s opinion regarding the cause of this adverse event is that this is procedure related.Since no ablations were performed and the tamponade occurred after the procedure, this event is being reported under both catheters involved separately.

Event Description

It was reported that a patient, (b)(6), female, underwent an atrial fibrillation (afib) procedure with a lasso 2515 nav eco variable catheter and athermocool smarttouch bi-directional navigation catheter and suffered a cardiac tamponade, which required surgical intervention.The event occurred after an attempt of an afib ablation procedure with carto 3 system that did not include radiofrequency ablation.The patient was under general anesthesia.A transseptal puncture was performed with a st.Jude sl0 8.5f sheath and brk-1 needle, using the guidance of transesophageal echocardiogram (tee).There were no issues during the transseptal puncture.However, the patient anatomy showed a very large left atrial appendage and a rotated axis of the heart.After the transseptal puncture, the lasso catheter was introduced in the left atrium (la) through the sheath and the smarttouch catheter was introduced with some difficulties also into the la through the same transseptal puncture site but without a second sheath.Some anatomical reconstruction was performed and then during a rotation of the lasso catheter, the transseptal was lost and the catheters returned to the right atrium.Several attempts were needed to go through the same puncture site back to the la.During the whole procedure, the patient was monitored with the tee and periodic blood pressure measurements, as well as heparinized properly with an anticoagulation maintained at 300-350s.When finishing the anatomical map of the right-sided veins, the anatomy was very challenging and unclear because it appeared differently to the patient's transverse aortic constriction.Due to the time it took, the whole reconstruction and the doubts about anatomy, the physicians decided to suspend the ablation.Sometime after the end of the procedure, the patient's blood pressure started to drop and an echocardiogram showed the patient suffered a tamponade.

• 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: 5442729
• MDR Text Key: 38416577
• Report Number: 9673241-2016-00085
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 01/22/2016

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 Model Number: D-1343-02-S
• Device Catalogue Number: D134302
• Device Lot Number: UNKNOWN_D-1343-02-S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/22/2016
• Initial Date FDA Received: 02/17/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 65 YR