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

Model Number D-1348-04-S

Device Problems High impedance (1291); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/12/2017

Event Type  malfunction  

Manufacturer Narrative

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.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.(b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation procedure with a thermocool® smarttouch® sf bi-directional nav catheter and coagulum was noticed on the catheter tip.During ablation, the impedance increased suddenly.The catheter was removed from the patient body and coagulum was noted at the tip of the catheter.The physician considered the coagulum to be excessive and believed there was a risk of stroke.The generator settings met the operating rules.The smartablate generator stopped the ablation immediately when the impedance cutoff value was reached.The generator was in power control mode with a temperature cut off 43°c and power cut off 30 watts.The noted temperature was 30°c, power was 30 w, and impedance was 150 ohms.There was no product problem.Saline solution was used for the catheter irrigation.The issues were resolved by replacing the catheter.The procedure was completed with no patient consequence and the patient has not exhibited any neurological symptoms since the procedure was completed.The impedance issue is not mdr reportable because if impedance exceeds the user-selected cut off, and the generator stops delivering rf energy as intended, then the risk to the patient is remote.However, the coagulum is mdr reportable since coagulum has poor adherence to catheters it could be a potential source of embolism.

Manufacturer Narrative

The bwi failure analysis lab received the device for evaluation on 08/25/2017.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.Manufacturer's ref.No: (b)(4).

Manufacturer Narrative

Manufacturer's ref.No: (b)(4) it was reported that a patient underwent an atrial fibrillation procedure with a thermocool® smarttouch® sf bi-directional nav catheter and coagulum was noticed on the catheter tip.During ablation, the impedance increased suddenly.The catheter was removed from the patient body and coagulum was noted at the tip of 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 and stockert compatibility and it was found within specifications.Then per the reported event, a coolflow pump test was performed and the catheter passed specifications.The catheter was irrigating correctly.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 customer complaint cannot be confirmed.

• Brand Name: THERMOCOOL® SMARTTOUCH® SF BI-DIRECTIONAL NAV 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 ; 33 technology drive; irvine, CA 92618 ; 9497893837
• MDR Report Key: 6768339
• MDR Text Key: 82028288
• Report Number: 9673241-2017-00621
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010176
• UDI-Public: (01)10846835010176(11)170301(17)180228(10)17639300L
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2018
• Device Model Number: D-1348-04-S
• Device Catalogue Number: D134804
• Device Lot Number: 17639300L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/13/2017
• Initial Date FDA Received: 08/04/2017
• Supplement Dates Manufacturer Received: 07/13/2017; 07/13/2017
• Supplement Dates FDA Received: 08/30/2017; 09/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1