MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (JUAREZ) EZ STEER¿ THERMOCOOL® NAV BI-DIRECTIONAL CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number D-1292-05-S

Device Problem Insufficient Information (3190)

Patient Problems Cardiac Tamponade (2226); Pericardial Effusion (3271)

Event Date 09/11/2015

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) has been reviewed and it was verified that device was manufactured in accordance with documented specifications and procedures.(b)(4).Methods: no testing methods performed.Results: no results available since no evaluation performed.Conclusion: device discarded by user, unable to follow-up.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, serial #: (b)(4).4.Distributed: acunav catheter, model #:m-5723-09, lot #: 0716qe122620.5.Non biosense webster: agilist nxt 8.5 f 94cm dilator deflectable sheath.(b)(4) are related to the same incident.(b)(4).

Event Description

It was reported that a (b)(6) female patient, underwent an idiopathic ventricular tachycardia (idvt) procedure with an ez steer navigational 4mm catheter and ez steer thermocool navigational 4mm catheter and suffered a cardiac tamponade which required a pericardiocentesis and surgical intervention.The patient's medical history is unknown.It was reported that after ablation, it was hard to get stability.Therefore, an agilis sheath was used and a pericardial effusion was noted on ultrasound.The event occurred during the mapping phase.The patient's blood pressure dropped and a pericardiocentesis was performed and approximately 200cc of fluid were removed.The patient then went to surgery.A transseptal puncture had not been performed.All hardware was working to specifications with no errors.Conscious sedation was used during the procedure.No other interventions were known at this time.The patient improved, however she did require extended hospitalization for further observation.It was believed that the site of the pericardial effusion did not occur at the site of ablation.The physician's opinion regarding the cause of this adverse event was that the pericardial effusion most likely occurred due to extra rigidity caused when using a deflectable sheath with the mapping catheter.Settings during the event include: power control mode / 30 watts with maximum 120s lesion time / no titration / 17ml/min for high flow and 2ml/min for low flow the ez steer navigational 4mm catheter was used earlier in the procedure.It was not in the patient's body and was not connected to the carto 3 system at the time of the adverse event.However, since the two ablation catheters were used during the procedure, biosense webster is taking a conservative approach and reporting this event under both these catheters.

• Brand Name: EZ STEER¿ THERMOCOOL® NAV BI-DIRECTIONAL CATHETER
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• 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: 5144690
• MDR Text Key: 28054255
• Report Number: 9673241-2015-00721
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Report Date: 09/15/2015

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2017
• Device Model Number: D-1292-05-S
• Device Catalogue Number: BNI75TCDFH
• Device Lot Number: 17100972M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/03/2014
• 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: 64 YR
• Patient Weight: 54