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

Model Number D-1327-02-S

Device Problems Material Too Rigid or Stiff (1544); Temperature Problem (3022)

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

Event Date 08/26/2014

Event Type  Injury  

Event Description

It was reported that a patient, female, underwent a atrial fibrillation (afib) procedure with a smart touch bidirectional catheter and suffered a pericardial effusion, (if applicable) which did not require intervention.The patient¿s medical history is unknown.While using the first smart touch bidirectional catheter (lot #: 17028614m) and during ablation, low temperature displayed on the carto 3 system.The temperature was unknown.The cable was exchanged with no resolution.The issue was resolved by exchanging the catheter.Upon request, additional information was provided on the event.The baseline temperature was between 30-32 c.The temperature typically stayed around 32 c while ablating.The minimal cut off value was unknown.The temperature dropped to 28 c.The catheter was exchanged with another smart touch bidirectional catheter (lot #: 17018373m).While using the second smart touch bidirectional catheter (lot #: 17018373m), the patient's blood pressure dropped towards the end of the procedure.Ice confirmed a pericardial effusion.No medical intervention was reported.The patient was reported to be in stable condition.

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.(b)(4).Concomitant products: carto 3 system, model #: m-4800-01, serial #: (b)(4).Stockert generator, model #: unknown, serial #: unknown.Coolflow pump, model #: unknown, serial #: unknown.Lasso navigational variable 12 pole catheter, model #: unknown, lot #: unknown.(b)(4).Event description continuation: upon request, additional information was provided on the event.The physician¿s opinion of the causality of the event was caused by the stiffness of the second smart touch bidirectional catheter used in the procedure.The physician also speculated that he may have burned somewhere too long because he did not have accurate temperature readings with the first smart touch bidirectional catheter (lot #: 17028614m).The physician also speculated that he may have paced rapidly while the bsx polaris coronary sinus (cs) catheter fell out of the cs.This bsx polaris coronary sinus catheter may have caused the effusion by penetrating the cardiac tissue.The next day the physician felt it was due to the stiffness of the second smart touch bidirectional catheter (lot #: 17018373m).A transseptal puncture was performed.However, the product information for the needle is unknown.The effusion was discovered after ablation and during testing for block.At the time, the bsx polaris coronary sinus catheter had fallen out of the cs and may have contributed/caused the effusion from rapid pacing while bouncing against the cardiac wall.The overall time for ablation at the site of the injury is unknown as the site of the effusion was undetermined.There is no further information about the hospitalization.Act was maintained at <250.Settings during the event include: power control mode / power averaged 30-35 watts / temperature cut-off was set at 40 degrees celsius / temperature ranged from 32-38 degrees celsius / irrigation flow setting was set at 30 ml/min.Per the physician¿s opinion and to be conservative, we will report this event under both smart touch bidirectional catheter¿s.However with the first smart touch bidirectional catheter (lot #: 17028614m), the temperature information provided seems as if it is normal temperatures were displayed.

Manufacturer Narrative

(b)(4).During ablation while using the first smart touch bidirectional catheter (lot #: 17028614m), low temperature displayed on the carto 3 system.The temperature was unknown.The cable was exchanged with no resolution.The issue was resolved by exchanging the catheter to another smart touch bidirectional catheter (lot #: 17018373m).It was also reported that the patient's blood pressure dropped towards the end of the procedure.Ice confirmed pericardial effusion.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 screening test and catheter passed both.The catheter was recognized by carto 3 system, no error messages were displayed and the catheter was properly visualized.The force feature was properly working.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 pericardial effusion remains unknown.The ifu states that careful catheter manipulation must be performed in order to avoid cardiac damage, perforation or tamponade.

• Brand Name: THERMOCOOL® SMARTTOUCH® BI-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: 4118182
• MDR Text Key: 4941120
• Report Number: 2029046-2014-00315
• 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: 08/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2015
• Device Model Number: D-1327-02-S
• Device Catalogue Number: D132702
• Device Lot Number: 17028614M
• Other Device ID Number: (01)10846835009170
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2014
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/26/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2014
• 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