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 Problems Charred (1086); Kinked (1339); Overheating of Device (1437); Device Displays Incorrect Message (2591); Infusion or Flow Problem (2964)

Patient Problems Transient Ischemic Attack (2109); Heart Failure (2206)

Event Date 11/10/2015

Event Type  Injury  

Manufacturer Narrative

No device was received for analysis at the time of submission of the initial 3500a.Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.As such, the investigation will be closed.If the complaint device is received in the future we will reopen the complaint and perform the investigation as appropriate.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.The device history record (dhr) for the lot number 17299245m has been reviewed and it was verified that device was manufactured in accordance with documented specifications and procedures.(b)(4).Biosense webster manufacturer's ref.No's (b)(4) are related to the same incident.(b)(4).Manufacturer's ref.No: (b)(4).Event description continuation: the physician¿s opinion regarding the cause of this adverse event is that it was due to the ablation catheter.The generator was reported to have been operating per specifications and not responsible for the event.The generator was set to power control mode at 35 watts.Other parameters were unknown.Patient was not given anticoagulation therapy during the procedure.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.The patient required extended hospitalization but it was not related to this event.Since this adverse event might result in permanent impairment of a body function or permanent damage to a body structure, this event is to be considered serious and mdr reportable.It was stated that the suspected device was the smart touch bidirectional catheter.Therefore, this event is being reported under this ablation catheter.The assessment has been made to also report this.

Event Description

It was reported that a patient underwent an ablation procedure for atrial fibrillation (afib) using a smart touch bidirectional catheter and a lasso navigational variable eco catheter and suffered a transient ischemic attack and heart failure.During the ablation phase, the high temperature error was observed and ablation was interrupted.The physician removed the smart touch bidirectional catheter and noticed char on the tip.Catheter flushing was attempted with no irrigation outflow.It was then that the physician noticed a kink on the smart touch bidirectional catheter shaft near the handle.Catheter integrity remained intact with no internal parts exposed.There had been no difficulty removing this catheter from the patient.The smart touch bidirectional catheter was replaced and the issue was resolved.The procedure was continued.The issues of the char on the tip, catheter irrigation issue, kink and high temperature are all indicative of not reportable issues.Later in the procedure, ultrasound revealed a clot on the tip of the lasso navigational variable eco catheter.The physician believes that the patient may have suffered a stroke.Additional information was received noting that the patient remained sedated and on the ventilator until the late afternoon on the following day.The patient had gone into heart failure possibly secondary to the 3-5 liters of fluid received during the procedure.The patient was reported to wake up in the afternoon the following day and be in stable condition.The patient did not require medical or surgical intervention.There have been no reports of the patient exhibiting neurologic symptoms since the procedure.

Manufacturer Narrative

The bwi failure analysis lab received the device for evaluation on (b)(6) 2015.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).

Manufacturer Narrative

(b)(4).It was reported that a patient underwent an ablation procedure for atrial fibrillation (afib) using a smart touch bidirectional catheter and a lasso navigational variable eco catheter.During the ablation phase, the high temperature error was observed and ablation was interrupted.The physician removed the smart touch bidirectional catheter and noticed char on the tip.Catheter flushing was attempted with no irrigation outflow.It was then that the physician noticed a kink on the smart touch bidirectional catheter shaft near the handle.Catheter integrity remained intact with no internal parts exposed.There had been no difficulty removing this catheter from the patient.The smart touch bidirectional catheter was replaced and the issue was resolved.The procedure was continued.Later in the procedure, ultrasound revealed a clot on the tip of the lasso navigational variable eco catheter.The physician believes that the patient may have suffered a stroke.Additional information was received noting that the patient remained sedated and on the ventilator until the late afternoon on the following day.The patient had gone into heart failure possibly secondary to the 3-5 liters of fluid received during the procedure.The patient was reported to wake up in the afternoon the following day and be in stable condition.The patient did not require medical or surgical intervention.There have been no reports of the patient exhibiting neurologic symptoms since the procedure.The returned device was visually inspected upon receipt and the shaft was found slightly bent at the client tip transition.During manufacturing all the catheters are inspected for visual damages before packaging.On line inspections are in place to prevent this type of damage/defect from leaving the facility.It remains unknown how the shaft was bent.Continuing with the visual inspection, char was not observed on catheter tip.An irrigation test was performed and the catheter passed, no occlusion was observed.The catheter was tested for electrical performance, temperature response and stockert compatibility and it was found within specifications.A deflection test was performed and the catheter passed.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.The force feature was evaluated and 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 failed visual inspection.However, all catheter features passed specifications.The root cause of the char, and the heart issue reported cannot be determined.

• 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 32599 ; MX 32599
• Manufacturer Contact: joaquin kurz ; 9497893837
• MDR Report Key: 5287025
• MDR Text Key: 33275383
• Report Number: 9673241-2015-00899
• 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,Followup
• Report Date: 11/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2016
• Device Model Number: D-1327-05-S
• Device Catalogue Number: D132705
• Device Lot Number: 17299245M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/19/2015
• 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