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 07/10/2020

Event Type  malfunction  

Manufacturer Narrative

A manufacturing record evaluation was performed for the finished device 30356855m number, and no internal actions related to the reported complaint was found during the review.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 (b)(6) year-old patient underwent cardiac ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter where thrombus on the tip electrode occurred.Thrombus attached to the tip electrode.After 4 hours since the start of the use of the thermocool® smart touch® sf bi-directional navigation catheter.The issue was resolved by changing the catheter to another one.The physician¿s commented that elapsed usage time may be a problem.After additional follow up it was reported that there was no particular impact on the patient.There was no patient consequence.

Manufacturer Narrative

On (b)(6)2020 , the bwi product analysis lab received the device for evaluation.On (b)(6)2020 , the product investigation was completed.It was reported that a 77 year-old patient underwent cardiac ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter where thrombus on the tip electrode occurred.Thrombus attached to the tip electrode.After 4 hours since the start of the use of the thermocool® smart touch® sf bi-directional navigation catheter.The issue was resolved by changing the catheter to another one.The physician¿s commented that elapsed usage time may be a problem.After additional follow up it was reported that there was no particular impact on the patient.There was no patient consequence.Device evaluation details: the device was visually inspected, and it was found in good normal conditions, no was found thrombus/clot on the tip, it could be remover during decontamination process.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, a cool flow pump test was performed, and it was found within specifications, no irrigation issues were observed.Additionally, irrigation test was performed, and it was found within specifications, the catheter was irrigating correctly, no irrigation issues were observed.A manufacturing record evaluation was performed for the finished device, and no internal actions related to the reported complaint condition were identified.The customer complaint cannot be confirmed since the device was found working correctly and no evidence of blood clot residues were observed on the catheter however, the root cause of the blood clot reported by the customer could be related to the usage of the device during the procedure, however this cannot be conclusively determined.The catheter passed specifications.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

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.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 for this event is ¿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: 10377494
• MDR Text Key: 202026624
• Report Number: 2029046-2020-01015
• 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
• Report Date: 07/10/2020

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: 02/24/2021
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30356855M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2020
• Initial Date Manufacturer Received: 07/10/2020
• Initial Date FDA Received: 08/07/2020
• Supplement Dates Manufacturer Received: 08/14/2020; 05/20/2021
• Supplement Dates FDA Received: 09/08/2020; 06/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 77 YR