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 06/18/2020

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 30356826m number, and no internal actions related to the reported complaint condition were identified.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and thrombus occurred.During the procedure a thrombus was confirmed on the tip electrode.The issue was resolved by changing the thermocool® smart touch® sf bi-directional navigation catheter to another one.The procedure was completed without patient's consequence.There was no report of intervention nor extended hospitalization.No further information is available.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.With the information available at present, this complaint is not reportable.

Manufacturer Narrative

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and thrombus occurred.During the procedure a thrombus was confirmed on the tip electrode.The issue was resolved by changing the thermocool® smart touch® sf bi-directional navigation catheter to another one.The procedure was completed without patient's consequence.On 7/16/2020, additional information was received indicating the generator used was a smartable generator.The device has been added to section d11.Concomitant med.Products.On 7/22/2020, the complaint product was returned to biosense webster inc.¿s (bwi) product analysis lab (pal) for evaluation.The catheter was visually inspected and it was found with several kinks on shaft and the dome in good condition.These findings are not considered to be mdr reportable.Device evaluation details: on 7/24/2020, the device evaluation was completed.The device was visually inspected, and it was found several kinks on shaft, the dome was found in good condition.Then, the catheter was tested on the generator and the temperature and impedance values were observed within specifications.A cool flow pump 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 complaint was found during the review.The customer complaint cannot be confirmed since the device was found working correctly and no evidence of clot residues were observed on the catheter however, the root cause of the clot reported by the customer could be related to the usage of the device during the procedure, however this cannot be conclusively determined.The root cause of several kinks in body shaft cannot be related to the manufacturing process since there is evidence that the device was manufactured in accordance with documented specification and procedures, it could be related to the handling of the device during the shipment, 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 ref.# (b)(4).

Manufacturer Narrative

The product investigation was re-open to include details to clarify that ¿no evidence of char residues were observed on the catheter;¿ 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: 10281568
• MDR Text Key: 199073516
• Report Number: 2029046-2020-00885
• 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: 06/18/2020

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: 03/02/2021
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30356826M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2020
• Initial Date Manufacturer Received: 06/18/2020
• Initial Date FDA Received: 07/16/2020
• Supplement Dates Manufacturer Received: 07/16/2020; 05/20/2021
• Supplement Dates FDA Received: 07/30/2020; 06/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SMARTABLATE GEN. KIT (JAPAN); THMCL SMTCH SF BID, TC, D-F; THMCL SMTCH SF BID, TC, D-F