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

Model Number D134805

Device Problem Patient Device Interaction Problem (4001)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/16/2020

Event Type  malfunction  

Manufacturer Narrative

If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent cardiac ablation procedure for atrial fibrillation (afib) with a thermocool® smart touch® sf bi-directional navigation catheter where thrombus occurred.There was no error and no discomfort during surgery.After the procedure was completed, when the catheter was removed from the patient¿s body, thrombus was confirmed to adhere to the tip.The event occurred after 7 hours since placed into the patient¿s body.The procedure was completed without patient's consequence.There was no error messages was shown during the procedure and there were no temperature- or flow related issues.Normal anticoagulation treatment was conducted during the procedure as usual.Heparinized saline was used as the irrigation fluid as usual.Thrombus/clot (likely char in this case) is an mdr-reportable issue.

Manufacturer Narrative

On 1/27/2021, the bwi product analysis lab received the device for evaluation.The product investigation was subsequently completed.It was reported that a patient underwent cardiac ablation procedure for atrial fibrillation (afib) with a thermocool® smart touch® sf bi-directional navigation catheter where thrombus occurred.There was no error and no discomfort during surgery.After the procedure was completed, when the catheter was removed from the patient¿s body, thrombus was confirmed to adhere to the tip.The event occurred after 7 hours since placed into the patient¿s body.The procedure was completed without patient's consequence.Device evaluation details: the returned device was visually inspected and it was found thrombus at the tip.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, the catheter was irrigating correctly, no irrigation issues were observed.A manufacturing record evaluation was performed for the finished device 30384635m number, and no internal action was found during the review.The customer complaint has been confirmed.The customer complaint regarding the thrombus on the tip has been verified.The root cause of the thrombus reported by the customer could be related to the usage 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).

• 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: 10981759
• MDR Text Key: 220721370
• Report Number: 2029046-2020-01908
• 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: 11/16/2020

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: 05/26/2021
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30384635M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2021
• Initial Date Manufacturer Received: 11/16/2020
• Initial Date FDA Received: 12/10/2020
• Supplement Dates Manufacturer Received: 01/27/2021; 05/20/2021
• Supplement Dates FDA Received: 02/22/2021; 06/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1