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

Model Number D134801

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 07/30/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.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 a procedure with a thermocool® smart touch® sf bi-directional navigation catheter and a thrombus issue occurred.After several minutes of ablation, an impedance rise occurred and thrombus was found to be attached to the catheter tip.The thrombus was removed and the flow was verified.The procedure continued and 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 impedance rise was assessed as not mdr reportable.Since it was not reported that the user-defined cut-off was exceeded, the potential that it could cause or contribute to a death, serious injury, or other significant adverse event, was remote.The thrombus issue was assessed as an mdr reportable issue.

Manufacturer Narrative

On 9/28/2020, the product investigation was completed as the complaint device was discarded.The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device 30373693m number, and internal action related to the complaint was found during the review.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

Additional information was received on 10/4/2020 stating that the patient did not exhibit any neurological symptoms since the procedure was completed.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

Manufacturer's reference number: (b)(4) this event was assessed as mdr reportable for a thrombus issue.During review on (b)(6)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, updated under ¿h6.Medical device problem code¿ from ¿coagulation in device or device ingredient¿ to ¿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: 10463113
• MDR Text Key: 206951194
• Report Number: 2029046-2020-01125
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010145
• UDI-Public: 10846835010145
• 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,Followup
• Report Date: 07/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/23/2021
• Device Model Number: D134801
• Device Catalogue Number: D134801
• Device Lot Number: 30373693M
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1