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

Model Number D134804

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 02/26/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that a patient underwent an atrial flutter right (r-afl) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and a thrombus issue occurred.It was reported that during atrial flutter (right) ablation procedure the smartablate tubing became disconnected from the thermocool® smart touch® sf bi-directional navigation catheter while it was in the patient.No ablations had taken place yet.However, when the catheter was removed from the patient's right atrium, 5-10 minutes without irrigation, thrombus was noted on the catheter tip.While outside of the patient¿s body, the thermocool® smart touch® sf bi-directional navigation catheter could not be adequately flushed as a result.The catheter was exchanged to continue the case successfully.There was no patient consequence.There were no error messages related to biosense webster equipment.No ablation has been performed prior to the event but the caller confirmed that the correct catheter was selected on smartablate preset.The irrigation was at a low setting of 2ml/min (standard for mapping).The patient was not anticoagulated because it was a right-sided procedure.Heparinized normal saline was used during the case.The patient had not exhibited any neurological symptoms since the procedure was completed.A smartablate generator and pump were in used during the procedure.On 3/17/2020, the complaint product was returned to biosense webster inc.¿s (bwi) product analysis lab (pal) for evaluation.Initial visual analysis observed the catheter tip appeared occluded with reddish material.The finding has been reviewed and assessed as mdr reportable for the thrombus issue consistent with the customer¿s initial complaint.

Manufacturer Narrative

It was reported that a patient underwent an atrial flutter right (r-afl) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and a thrombus issue occurred.It was reported that during atrial flutter (right) ablation procedure the smartablate tubing became disconnected from the thermocool® smart touch® sf bi-directional navigation catheter while it was in the patient.No ablations had taken place yet.However, when the catheter was removed from the patient's right atrium, 5-10 minutes without irrigation, thrombus was noted on the catheter tip.While outside of the patient¿s body, the thermocool® smart touch® sf bi-directional navigation catheter could not be adequately flushed as a result.The catheter was exchanged to continue the case successfully.There was no patient consequence.Device evaluation details: the device evaluation has been completed.First visual inspection was performed, and it was found that the tip appears occluded with a reddish material.Second visual inspection was performed, and thrombus was found on the tip dome.Per the event, the electrical test was performed on the catheter and it was found within specifications; no electrical malfunction was observed.Additionally, the catheter was tested on the generator and the temperature and impedance values were observed within specifications.Then irrigation feature was tested and the holes of the distal part was not irrigating since thrombus was occluding the holes.A manufacturing record evaluation was performed, and no internal action related to the reported complaint were identified.The customer complaint regarding thrombus on the tip was confirmed however, the root cause of the thrombus reported by the customer could be related to the usage of the device during the procedure, however, this cannot be conclusively determined.In addition, the catheter was found working properly.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

The product investigation was re-open to include details to clarify that ¿char was found on the tip dome¿ during visual analysis/inspection of the device.The customer complaint was confirmed however, the root cause of the issue reported by the customer could be related to the usage of the device during the procedure, however, this cannot be conclusively determined.In addition, the catheter was found working properly.Manufacturer's ref.# (b)(4).Initially 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, 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: 9872420
• MDR Text Key: 200483224
• Report Number: 2029046-2020-00465
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010176
• UDI-Public: 10846835010176
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 02/26/2020

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: 11/14/2020
• Device Model Number: D134804
• Device Catalogue Number: D134804
• Device Lot Number: 30317612M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2020
• Initial Date Manufacturer Received: 02/26/2020
• Initial Date FDA Received: 03/24/2020
• Supplement Dates Manufacturer Received: 03/31/2020; 05/20/2021
• Supplement Dates FDA Received: 04/14/2020; 06/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SMARTABLATE GENERATOR KIT-US; SMARTABLATE PUMP KIT-US