MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL SMART TOUCH SF BI-DIRECTIONAL NAVIGATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number D134805

Device Problems Coagulation in Device or Device Ingredient (1096); Device Contamination with Body Fluid (2317)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/05/2020

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone: (b)(6).If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) procedure with a thermocool® smart touch® sf bi-directional navigation catheter and a thrombus issue occurred.It was reported that during a right pulmonary vein isolation (pvi) ablation procedure, when the thermocool® smart touch® sf bi-directional navigation catheter was taken out of the patient¿s body to be replaced with a pentaray catheter in order to create map of the left pulmonary vein, a thrombus was noticed adhered to its tip.After the procedure, patient¿s consciousness was confirmed, and the patient could move his limbs without any issue.The procedure was completed without patient's consequence.The ablation started from the front left, and the impedance did not change from the roof to the posterior wall, so it seems that a thrombus was formed by the ablation per roof.Since there was a time when the activated clotting time (act) was about 260; however, the timing may be wrong.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.The thrombus adhered to the devices tip was assessed as an mdr reportable issue.

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on 12/10/2020.The device evaluation was completed on 12/24/2020 it was reported that a patient underwent an atrial fibrillation (afib) procedure with a thermocool® smart touch® sf bi-directional navigation catheter.It was reported that during a right pulmonary vein isolation (pvi) ablation procedure, when the thermocool® smart touch® sf bi-directional navigation catheter was taken out of the patient¿s body to be replaced with a pentaray catheter in order to create map of the left pulmonary vein, a thrombus was noticed adhered to its tip.After the procedure, patient¿s consciousness was confirmed, and the patient could move his limbs without any issue.The procedure was completed without patient's consequence.The ablation started from the front left, and the impedance did not change from the roof to the posterior wall, so it seems that a thrombus was formed by the ablation per roof.Since there was a time when the activated clotting time (act) was about 260; however, the timing may be wrong.The device was visually inspected and thrombus was observed in the tip dome.Then, the catheter was tested on the generator and the temperature and impedance values were observed within specifications.Additionally, an irrigation test was performed and it was found that some holes were not irrigating correctly, due to the thrombus found blocking some irrigation holes.A manufacturing record evaluation was performed, and no internal actions related to the reported complaint condition were identified.The customer complaint was confirmed.Reddish material that may be related to the reported thrombus was observed at the tip and causing the incorrect irrigation; however, the device was found within specification.H6: component code of ¿appropriate term/code not available" represents the thrombus.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

Additional information was received on 1/24/2021.Smart ablate generator was used.The patient did not develop any neurological symptom since the procedure was completed.No error messages were observed.Additional information was received on 2/3/2021.The physician confirmed carto data retrospectively and expected thrombus formation timing.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

Manufacturer's reference number: (b)(4).This event was assessed as mdr reportable for a thrombus issue.During review on 5/20/2021, a correction was noted to the assessment as this event should have been assessed as char which is not mdr reportable.Char is a physical phenomenon of radio frequency energy delivery and can be the normal result of the ablation process.The presence of char on the electrodes does not represent a serious injury in itself, nor is it necessarily the result of device malfunction.Therefore, updated under ¿h6.Medical device problem code¿ from ¿coagulation in device or device ingredient¿ to ¿device contamination with body fluid¿.

• Brand Name: THERMOCOOL SMART TOUCH SF BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 10776118
• MDR Text Key: 247667315
• Report Number: 2029046-2020-01618
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/05/2020

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: 07/30/2021
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30410057M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2020
• Initial Date Manufacturer Received: 10/05/2020
• Initial Date FDA Received: 11/02/2020
• Supplement Dates Manufacturer Received: 12/10/2020; 01/24/2021; 05/20/2021
• Supplement Dates FDA Received: 01/08/2021; 02/17/2021; 06/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK_PENTARAY; UNK_SMARTABLATE GENERATOR