MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (JUAREZ) THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number	D-1313-04-S
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	05/19/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The bwi failure analysis lab received the device for evaluation.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.Concomitant products: carto 3 system, model #: m-4800-01, serial #: (b)(4).Stockert 70 system, model #: m-5463-01, serial #: (b)(4).Cool flow pump, model #: m-5491-02, serial #: (b)(4).Soundstar eco catheter, model #: m-5723-15.(b)(4).
Event or Problem Description
It was reported that a patient underwent a right ventricular outflow tract (rvot) ablation procedure for an idiopathic ventricular tachycardia with an ez steer thermocool sf navigational catheter and suffered a cardiac tamponade requiring a pericardiocentesis.After waiting 10 minutes after the last ablation, the physician wanted to use the intracardiac ultrasound with the existing soundstar eco catheter to scan the heart for an effusion as a routine scan.The patient was not symptomatic.Pericardial fluid was seen at that time.The patient was sedated further for intervention.The pericardiocentesis yielded 130cc.A drain was left in place.The patient transferred to the intensive care unit for monitoring.The patient did require extended hospitalization due to the drain which was placed.The patient was reported to be in stable condition at the time of report.The patient fully recovered with no residual effects.There was no issue noted with the catheter.There were no error messages at the time of the event.However, initially a, "temp limiter" error came on the stockert generator with the first ablation attempt.A reprocessed cable was used and that was immediately switched for a new cable and then there were no error messages with ablation.There was no transseptal puncture performed.The flow setting under 30 watts was 8ml/min and above 30 watts the flow was 17ml/min.The diagnosis was frequent premature ventricular contractions.The physician did not provide causality opinion.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.
Additional Manufacturer Narrative
(b)(4).It was reported that a patient underwent a right ventricular outflow tract (rvot) ablation procedure for an idiopathic ventricular tachycardia with an ez steer thermocool sf navigational catheter.After waiting 10 minutes after the last ablation, the physician wanted to use the intracardiac ultrasound with the existing soundstar eco catheter to scan the heart for an effusion as a routine scan.The patient was not symptomatic.Pericardial fluid was seen at that time.The patient was sedated further for intervention.The pericardiocentesis yielded 130cc.A drain was left in place.The patient transferred to the intensive care unit for monitoring.The patient did require extended hospitalization due to the drain which was placed.The patient was reported to be in stable condition at the time of report.The patient fully recovered with no residual effects.There was no issue noted with the catheter.The returned device was visually inspected and it was found in normal conditions.Per the event, the catheter was tested for electrical performance, temperature response and generator test and it was found within specifications.A deflection test was performed and the catheter passed.The catheter was evaluated for eeprom, and the functionality of the magnetic sensor of the catheter was tested on carto system.The catheter was recognized by carto 3 system, no error messages were displayed and the catheter was properly visualized.Eeprom data demonstrates the catheter was properly calibrated during manufacturing.An irrigation test was performed and the catheter passed, no occlusion was observed.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.The catheter passed all specifications.The root cause of the tamponade remains unknown.The instructions for use (ifu) states that careful catheter manipulation must be performed in order to avoid cardiac damage, perforation or tamponade.

• Brand Name: THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER, INC. (JUAREZ); circuito interior norte #1820; parque industrial salvacar; juarez, chihuahua 32599 ; MX 32599
• MDR Report Key: 5730895
• Report Number: 9673241-2016-00376
• Device Sequence Number: 1048218
• Product Code: LPB
• UDI-Device Identifier: 10846835003260
• UDI-Public: (01)10846835003260(11)150917(17)160831(10)17318855L
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P030031/S025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2016

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2016
• Device Model Number: D-1313-04-S
• Device Catalogue Number: BNI35FJCT
• Device Lot Number: 17318855L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2016
• Was the Report Sent to FDA?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/19/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/16/2016
• Supplement Report FDA Received Date: 07/14/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention