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

Model Number D-1327-05-S

Device Problem Difficult To Position (1467)

Patient Problems Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226); Pericardial Effusion (3271)

Event Date 07/09/2014

Event Type  Injury  

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.Lot number reported is 16087798m.Concomitant product: c3 external reference patch; model #: d-1283-02; lot #: oem_d-1283-02.(b)(4).Description continuation: there were 3 short ablations much earlier in the procedure but not related to the event.Settings during the event include: temperature control mode / power setting was set to 40 watts / flow setting 30ml/min / used with a st.Jude agilis large curl.The power was titrated during ablation.It reached its target setting within 5 ¿ 10 seconds.The act was maintained during the procedure between 300-350.Per 21 cfr, part 803, this complaint is reportable.

Event Description

It was reported that a patient, (b)(6) male, underwent a ischemic ventricular tachycardia (isvt) procedure with a smart touch bidirectional catheter, suffered a cardiac tamponade, which required insertion of a pericardial drain.It was noted that this patient had a medical history of ischemic heart disease, cardiomyopathy, icd in situ and had a previous coronary stent insertion.Before the event, the physician had difficulty in manipulating the catheter to at least one area of interest which was assumed to be due to specific anatomy.The event occurred during the mapping phase.Approximately five hours into a complex ventricular tachycardia (vt) ablation, it was noted that the systemic blood pressure was a little lower than previously recorded and that a previously tolerated vt was no longer tolerated.An echocardiogram revealed a pericardial effusion which was just starting to cause a tamponade.It was thought to have been just at the point of causing systolic right ventricle (rv) collapse.It was drained and the blood pressure settled.The catheter was removed without difficulty.The patient did not require hospitalization.The procedure was completed successfully.The patient fully recovered with no residual effects.The prognosis for the patient is excellent.The physician¿s opinion regarding the cause of this adverse event is that it was possibly procedure or device related most likely while attempting to map from the coronary sinus which proved difficult to enter possibly related to the issue in manipulating the catheter.The deflection of the catheter at the end of the procedure was not deflecting enough.This issue was not thought as the cause of the complication.

Manufacturer Narrative

Manufacturer's ref.No: (b)(4).It was reported that a patient, (b)(6), male, underwent a ischemic ventricular tachycardia (isvt) procedure with a smart touch bidirectional catheter, suffered a cardiac tamponade, which required insertion of a pericardial drain.It was noted that this patient had a medical history of ischemic heart disease, cardiomyopathy, icd in situ and had a previous coronary stent insertion.Before the event, the physician had difficulty in manipulating the catheter to at least one area of interest which was assumed to be due to specific anatomy.The event occurred during the mapping phase.Approximately five hours into a complex ventricular tachycardia (vt) ablation, it was noted that the systemic blood pressure was a little lower than previously recorded and that a previously tolerated vt was no longer tolerated.An echocardiogram revealed a pericardial effusion which was just starting to cause a tamponade.It was thought to have been just at the point of causing systolic right ventricle (rv) collapse.It was drained and the blood pressure settled.The catheter was removed without difficulty.The patient did not require hospitalization.The procedure was completed successfully.The patient fully recovered with no residual effects.The prognosis for the patient is excellent.The physician¿s opinion regarding the cause of this adverse event is that it was possibly procedure or device related most likely while attempting to map from the coronary sinus which proved difficult to enter possibly related to the issue in manipulating the catheter.The deflection of the catheter at the end of the procedure was not deflecting enough.This issue was not thought as the cause of the complication.There were 3 short ablations much earlier in the procedure but not related to the event.Settings during the event include: temperature control mode / power setting was set to 40 watts / flow setting 30ml/min / used with an st.Jude agilis large curl.The power was titrated during ablation.It reached its target setting within 5 ¿ 10 seconds.The act was maintained during the procedure between 300-350.The returned device was visually inspected upon receipt and it was found in normal conditions.Per the event, the catheter was tested for electrical performance, temperature response and stockert compatibility and it was found within specifications.Furthermore, an irrigation test was performed and the catheter passed, no occlusion was observed.The catheter was also evaluated for carto 3 and the catheter was recognized by carto 3 system, no error messages were displayed and the catheter was properly visualized.Force feature was properly working.Finally, a deflection test was performed and the catheter failed.Afterwards, the catheter was dissected and it was noticed that the t bars slid down from its place.However, this issue is not related with the pericardial effusion.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 failed the deflection test, but the root cause of the pericardial effusion remains unknown.The ifu states that careful catheter manipulation must be performed in order to avoid cardiac damage, perforation or tamponade.An internal corrective action has been opened to investigate the t bar issue.

• Brand Name: THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• 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 3259 9; MX 32599
• Manufacturer Contact: jaime chavez ; 15715 arrow highway; irwindale, CA 91706 ; 9098398483
• MDR Report Key: 3965322
• MDR Text Key: 22209526
• Report Number: 9673241-2014-00282
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P030031/S053
• 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,Followup
• Report Date: 07/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2015
• Device Model Number: D-1327-05-S
• Device Catalogue Number: D132705
• Device Lot Number: UNK_D-1327-05-S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2014
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/09/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/28/2014
• 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): Life Threatening; Required Intervention
• Patient Age: 78 YR