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

Catalog Number D134805

Device Problem Coagulation in Device or Device Ingredient (1096)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/11/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Since the product was not returned for analysis, no product failure analysis can be conducted, and no determination of possible contributing factors could be made.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 30255929m number, and no internal actions related to the complaint was found during the review.Manufacturer's reference # (b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) procedure with a thermocool® smart touch® sf bi-directional navigation catheter and a thrombus issue occurred.During the procedure, thrombus was discovered on the tip of the thermocool® smart touch® sf bi-directional navigation catheter.The catheter was replaced, and the procedure was completed without patient consequence.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.The thrombus on the tip of the catheter was assessed as a reportable issue.

Manufacturer Narrative

The biosense webster, inc.Product analysis lab received the device for evaluation on (b)(6) 2019.Upon initial visual inspection, it was reported that there was dark red / black material on the dome of the catheter.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.Manufacturer's reference # (b)(4).

Manufacturer Narrative

It was reported that a patient underwent an atrial fibrillation (afib) procedure with a thermocool® smart touch® sf bi-directional navigation catheter and a thrombus issue occurred.Investigation analysis was completed on (b)(6) 2019.The device was visually inspected and dark red material was found on the dome.During the second visual inspection, thrombus was identified as the material on the dome.An 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.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, and no non-conformities related to the complaint was found during the review.The customer complaint was confirmed.The root cause of the thrombus found on the dome cannot be determined however, this could be related to the procedure.Additional information was received on december (b)(6)2019.Smart ablate generator was used during the procedure.There were no error messages and the physician/user did not see any product problem.D11 has been updated to include the smartablate generator.Manufacturer's ref.No: (b)(4).

• 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: 9282423
• MDR Text Key: 191815396
• Report Number: 2029046-2019-03855
• 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: 10/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/22/2020
• Device Catalogue Number: D134805
• Device Lot Number: 30255929M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2019
• Date Manufacturer Received: 12/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK_SMARTABLATE GENERATOR.