MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC (IRWINDALE) NAVISTAR® THERMOCOOL®; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number D-1197-16-S

Device Problems Signal Artifact/Noise (1036); High impedance (1291)

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

Event Date 05/18/2014

Event Type  Injury  

Event Description

It was reported that a patient, (b)(6) year old male, underwent an atrial fibrillation (afib) procedure with a navistar thermocool and suffered a cardiac tamponade, which required surgical intervention.The patient¿s medical history is unknown.There were noise on the smart touch catheters during the mapping and ablation stages of the procedure.The system often required these catheters to be zeroed and the impedance would measure high at 300 ohm in specific areas around the right superior pulmonary vein (rspv) of the mapped chamber.The catheter was pulled out for char inspection, but no char was found.After replacing the cables, the smart touch catheter was replaced with new one.Signal issues had improved but the second smart touch catheter also had some noise on the intracardiac (ic) signals as well.Upon customer request, a third catheter non smart touch (navistar thermocool) was opened and there was no noise issue.The signal and impedance issues were not indicative of a reportable event.After the navistar thermocool catheter which was in for a very short time, it was noted that the patient¿s blood pressure dropped.The procedure was terminated as the patient suffered a cardiac tamponade.The local (b)(4) lab team was unable to control the tamponade event.Therefore, the patient was transferred to the operating room and was operated.According to the physician, no catheter hole was observed on the heart.This indicates that the catheter did not go through the atrium wall.The surgeon described some kind of condensation in the left vein area that might be related to the event (might be a small rapture ¿ that was closed by coagulum).

Manufacturer Narrative

The product was discarded, therefore no product failure analysis can be conducted and device malfunction cannot be confirmed.Device history report (dhr) review cannot be conducted because no lot number was provided by the customer.Concomitant products: reprocessed coronary sinus catheter.Reprocessed lasso catheter.Smart touch unidirectional catheter: model #: d-1336-01-s, lot #: 16030891m.Smart touch unidirectional catheter: model #: d-1336-01-s, lot #: 16030896m.(b)(4).Event description continuation: the physician did experience difficulty in manipulating the catheter as the patient moved a lot during the procedure and often had very deep snoring.The patient received several ablations prior to the event.The event was detected after the left veins were ablated.The rf generator was set to power-control mode at 25-30w.There was no power titration.The temperature was set to 50c and the flow setting was set to 30ml/min during ablation.The sheath used was the sweartz transseptal fix by st.Jude medical.The act was maintained at <250+.The force levels were in the range of 3-15gr and the merge map used in the procedure was not in good correlation with anatomy.The patient required extended hospitalization and intervention.The patient fully recovered with no residual effects.The physician¿s opinion regarding the cause of this adverse event is that it might not be related to the catheter noise issues reported and was procedure related.Per 21 cfr, part 803, the patient event is reportable.

• Brand Name: NAVISTAR® THERMOCOOL®
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): BIOSENSE WEBSTER, INC (IRWINDALE); 15715 arrow highway; irwindale CA 91706
• Manufacturer (Section G): BIOSENSE WEBSTER, INC (IRWINDALE); 15715 arrow highway; irwindale CA 91706
• Manufacturer Contact: jaime chavez ; 15715 arrow highway; irwindale, CA 91706 ; 9098398483
• MDR Report Key: 3875725
• MDR Text Key: 4455770
• Report Number: 2029046-2014-00167
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D-1197-16-S
• Device Catalogue Number: NI75TCDH
• Device Lot Number: UNKNOWN_D-1197-16-S IRW
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/18/2014
• 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: 40 YR