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

Model Number D134801

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 03/13/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that a patient underwent an ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and a thrombus issue occurred.It was reported that during an ablation procedure, when the thermocool® smart touch® sf bi-directional navigation catheter was removed from the cardiac cavity, a blood clot was found adhered to the catheter tip.The clot was removed, but although flushing was conducted, the irrigation could not come out from the catheter tip.The thermocool® smart touch® sf bi-directional navigation catheter was replaced and the procedure was completed.No patient consequences were reported.The costumer's reported catheter tip occlusion/no irrigation is considered to not be mdr reportable since the issue is highly detectable by the physician and the potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.However, the issue of thrombus/clot is considered an mdr reportable malfunction.

Manufacturer Narrative

It was reported that a patient underwent an ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and a thrombus issue occurred.It was reported that during an ablation procedure, when the thermocool® smart touch® sf bi-directional navigation catheter was removed from the cardiac cavity, a blood clot was found adhered to the catheter tip.The clot was removed, but although flushing was conducted, the irrigation could not come out from the catheter tip.The thermocool® smart touch® sf bi-directional navigation catheter was replaced and the procedure was completed.No patient consequences were reported.Device evaluation details: the device evaluation has been completed.The device was inspected and it was found in good normal condition.The catheter was connected to the stockert generator and the temperature and impedance were observed correctly.In addition, the catheter was irrigating correctly, no malfunctions were observed.A manufacturing record evaluation was performed, and no internal actions related to the reported complaint were identified.The customer complaint cannot be confirmed, since the device was found working correctly.The root cause of the thrombus could be related to the usage of the device during the procedure.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer¿s ref # (b)(4).

Manufacturer Narrative

On 4/6/2020, the complaint product was returned to biosense webster inc.¿s (bwi) product analysis lab (pal) for evaluation.Initial visual analysis observed there was no visual damage or anomalies.The product analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.Additionally, if additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# pc-(b)(4).

Manufacturer Narrative

The product investigation was re-open to include details to clarify that ¿char was not observed¿ during visual analysis/inspection of the device.Manufacturer¿s ref # (b)(4) initially this event was assessed as mdr reportable for a thrombus/blood clot issue.During review on (b)(6) 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, the h6.Medical device problem code of ¿device contamination with body fluid¿ is being used to represent the issue.

• 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: 9920936
• MDR Text Key: 201889644
• Report Number: 2029046-2020-00515
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010145
• UDI-Public: 10846835010145
• 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: 03/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/15/2020
• Device Model Number: D134801
• Device Catalogue Number: D134801
• Device Lot Number: 30276817M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2020
• Date Manufacturer Received: 05/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1