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

Model Number D134805

Device Problem Mechanical Jam (2983)

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

Event Date 07/09/2021

Event Type  malfunction  

Manufacturer Narrative

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 an unknown patient underwent a supraventricular tachycardia/ wolff-parkinson-white (svt/wpw) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The thermocool stsf catheter would get stuck.The thermocool stsf catheter was not fully deflecting.The caller stated that the thermocool stsf catheter would get stuck.The thermocool stsf catheter was replaced, and the issue was resolved.The procedure continued successfully.The device was not entrapped.No patient consequences were reported.The curve of the catheter was not stuck/jammed in a full deflected position.The knob/piston was not unable to be turned and/or pushed up and down.There was no difficulty in removing the catheter.The sheath was abbott sr0.There was no detachment of any component.The loop/tip did not become unknotted.The issue did not result in exposure of any internal catheter components or sharp edges.The event did not require medical or surgical intervention.The patient did not require extended hospitalization.The stuck deflection is mdr-reportable.

Manufacturer Narrative

On 24-sep-2021, the product investigation was completed as the complaint device was not returned.It was reported that an unknown patient underwent a supraventricular tachycardia/ wolff-parkinson-white (svt/wpw) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The thermocool stsf catheter would get stuck.The thermocool stsf catheter was not fully deflecting.The caller stated that the thermocool stsf catheter would get stuck.The thermocool stsf catheter was replaced, and the issue was resolved.The procedure continued successfully.Device investigation details: since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device (b)(4) number, and no 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).

• Brand Name: THERMOCOOL SMART TOUCH SF BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• MDR Report Key: 12257529
• MDR Text Key: 264477795
• Report Number: 2029046-2021-01228
• 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
• Type of Report: Initial,Followup
• Report Date: 07/09/2021

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: 04/04/2022
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30531279M
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/09/2021
• Initial Date FDA Received: 08/02/2021
• Supplement Dates Manufacturer Received: 09/24/2021
• Supplement Dates FDA Received: 09/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ABBOTT SR0 SHEATH; ABBOTT SR0 SHEATH