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

Model Number D-1336-02-S

Device Problem Material Too Rigid or Stiff (1544)

Patient Problems High Blood Pressure/ Hypertension (1908); Perforation (2001); Cardiac Tamponade (2226)

Event Date 10/31/2014

Event Type  Injury  

Event Description

It was reported that a patient, (b)(6), female, underwent an atrial fibrillation procedure with a thermocool® smart touch¿ electrophysiology catheter and suffered a cardiac tamponade.During procedure, patient had a quick rise in blood pressure and ice confirmed perforation.A pericardiocentesis was performed and 400 cc of fluid was removed.The patient was reported to be in stable condition at the time bwi followed-up with the physician.The patient did not required hospitalization.A transseptal puncture was performed and the event occurred during ablation phase.The patient received anticoagulation, the targeted range was 250 ¿ 300's.The physician¿s opinion regarding the cause of this adverse event is that this is patient¿s condition (patient¿s age with sick heart and high act > 400's) as well as the stiffness of the catheter may have played a role.Settings during the event include: power control at 30 w., flow setting at 30 cc/min, a sjm brk needle and a sjm sl0 8.5 f sheath were used (non bwi products).

Manufacturer Narrative

The bwi failure analysis lab received the device for evaluation on november 20, 2014.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 medical products: product: carto® 3 system, us catalog # fg540000, serial # (b)(4); product: stockert 70 rf generator, us catalog # s7001, serial # (b)(4); product: coolflow® irrigation pump, us catalog # cfp002, serial # (b)(4); product: lasso® nav eco variable catheter, us catalog # d134301, lot # 17037214l; product: soundstar® 3d diagnostic ultrasound catheter, us catalog # sndstr10, lot # s1413779.(b)(4).

Manufacturer Narrative

(b)(4) it was reported that a patient, (b)(6), female, underwent an atrial fibrillation procedure with a thermocool smart touch electrophysiology catheter and suffered a cardiac tamponade.During procedure, patient had a quick rise in blood pressure and ice confirmed perforation.A pericardiocentesis was performed and 400 cc of fluid was removed.The patient was reported to be in stable condition at the time bwi followed-up with the physician.The patient did not required hospitalization.A transseptal puncture was performed and the event occurred during ablation phase.The patient received anticoagulation, the targeted range was 250 ¿ 300 s.The physician¿s opinion regarding the cause of this adverse event is that this is patient¿s condition (patient¿s age with sick heart and high act > 400 s) as well as the stiffness of the catheter may have played a role.The bwi failure analysis lab received the device for evaluation.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.The catheter was recognized by carto 3 system, no error messages were displayed and the catheter was properly visualized.Finally, a deflection test was performed and the catheter passed.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 ifu states that careful catheter manipulation must be performed in order to avoid cardiac damage, perforation or tamponade.Management is notified of failure analysis results using monthly complaint trend reporting.No significant trends have been identified at this time; therefore no capa activity is required.

• Brand Name: THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• 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: 4272154
• MDR Text Key: 20659763
• Report Number: 2029046-2014-00438
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030031/S053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2015
• Device Model Number: D-1336-02-S
• Device Catalogue Number: D133602
• Device Lot Number: 17044348M
• Other Device ID Number: (01)10846835009002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2014
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/31/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/25/2014
• 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: 80 YR