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 06/19/2020

Event Type  malfunction  

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.A manufacturing record evaluation was performed for the finished device 30376762m number, and internal action related to the reported complaint was found during the review.Manufacturer's ref.# (b)(4).

Event Description

It was reported that a patient underwent atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and thrombus formation occurred.During the procedure a thrombus was confirmed on the tip electrode.The issue was resolved by changing the catheter to another one.The procedure was completed without patient's consequence.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.Should more information becomes available in the future; the reportability decision will be reassessed.

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation.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.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 7/30/2020, the product investigation was completed.It was reported that a patient underwent atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and thrombus formation occurred.During the procedure a thrombus was confirmed on the tip electrode.The issue was resolved by changing the catheter to another one.The procedure was completed without patient's consequence.Device evaluation details: the device was visually inspected and it was found in good conditions.The catheter was tested on the generator, temperature and impedance values were observed within specifications.Then, a cool flow pump test was performed, and not irrigate, the catheter was dissected and the irrigation tube was found broken.A manufacturing record evaluation was performed and no internal action related to the reported complaint was found during the review.The customer complaint regarding thrombus was not confirmed.The root cause of the irrigation tube broken could be related to handling of the device during the procedure however, this cannot be conclusively determined.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

The product investigation was re-open to include details to clarify that ¿complaint catheter was inspected and it was found in good normal condition, no char was observed.¿ during visual analysis/inspection of the device.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: 10287729
• MDR Text Key: 202106540
• Report Number: 2029046-2020-00891
• 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: 06/19/2020

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: 03/29/2021
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30376762M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2020
• Initial Date Manufacturer Received: 06/19/2020
• Initial Date FDA Received: 07/17/2020
• Supplement Dates Manufacturer Received: 07/22/2020; 07/30/2020; 05/20/2021
• Supplement Dates FDA Received: 07/22/2020; 08/14/2020; 06/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SMARTABLATE SYS -GENERATOR-JPN; THMCL SMTCH SF BID, TC, D-F