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 06/29/2020

Event Type  malfunction  

Manufacturer Narrative

The device evaluation has been completed.The returned device was visually inspected and it was in good normal condition.Per the event, the catheter was closely inspected and no thrombus evidence was found in the catheter.Also, the catheter was tested for stockert generator compatibility and it was found within specifications.Finally, a cool flow pump test was performed and it was found within specifications.The catheter was irrigating correctly and no irrigation issues were observed.A manufacturing record evaluation was performed for the finished device number and no internal action related to the complaint was found during the review.The customer complaint regarding the thrombus on the tip was not verified.The device was found working in specification.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.(b)(6).Manufacturer's ref.# (b)(4).

Event Description

It was reported that a patient underwent cardiac ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter where blood clot occurred.Immediately after the thermocool® smart touch® sf bi-directional navigation catheter was inserted into the patient¿s body, a signal noise occurred at the on poles 1-2 on both the carto3 and the recording system.The cable was reconnected, the cable was changed but the issue continued, the issue was resolved by changing the catheter to another one.After the pentaray nav eco catheter was inserted into the patient¿s body, after about 30 seconds since fam was started, error code 116 occurred.The cable was reconnected, the cable was changed but error remaining, so the issue was resolved by changing the catheter to another one.After both pvis were completed, the second thermocool® smart touch® sf bi-directional navigation catheter was taken out of the body, the irrigation was stopped for about 20 minutes, and when the physician looked at the tip of the catheter to insert it again into the body, a blood clot was attached.The physician decided to stop the irrigation, removed the blood clot, flushed again, and performed touch-up.After that, when the catheter was pulled out and checked, there was a blood clot.When the flush was executed, the saline did not come out from the tip.The procedure ended at this point without patient's consequence.On (b)(6) 2020 the caller confirmed that there was clot attached to the tip.The customer¿s reported noise on the first thermocool® smart touch® sf bi-directional navigation catheter is not considered to be mdr reportable since the risk to the patient is low.Also, the cusotmer¿s reported error code 116 with the pentaray nav eco catheter is not considered mdr reportable since the incidence of magnetic sensor error is easy detectable by the user and the potential risk that it could cause or contribute to a serious injury or death is remote.This event has been assessed as mdr reportable malfunction of the clot formation.

Manufacturer Narrative

The product investigation was re-open to include details to clarify that ¿no char was found on the tip¿ 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 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: 10577051
• MDR Text Key: 241259121
• Report Number: 2029046-2020-01315
• 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
• Report Date: 06/29/2020

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: 02/14/2021
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30349503M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2020
• Initial Date Manufacturer Received: 06/29/2020
• Initial Date FDA Received: 09/23/2020
• Supplement Dates Manufacturer Received: 05/20/2021
• Supplement Dates FDA Received: 06/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTO 3 SYSTEM; PENTARAY NAV ECO 7FR, D, 2-6-2; PENTARAY NAV ECO 7FR, D, 2-6-2; SMARTABLATE GEN. KIT ((B)(6)); THMCL SMTCH SF BID, TC, D-F; UNKNOWN CATHETER CABLE; UNKNOWN RECORDING SYSTEM