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

Model Number D134805

Device Problems Crack (1135); Entrapment of Device (1212); Mechanical Jam (2983)

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

Event Date 07/07/2021

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone: (b)(6).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 an unknown patient underwent an unknown ablation procedure with thermocool® smart touch® sf bi-directional navigation catheter.The ablation catheters get stuck.When it was going to go to the trans aortic for ablation while mapping the lateral side of the mitral valve.The ablation catheters got stuck, when the physician takes it out, the spring part of the stsf is very easy to remove.The catheter replacement was performed as a precaution, and the procedure was successfully completed.It was confirmed that there was no problem with the patient's echo, etc.The procedure was completed without patient's consequence.The medical device entrapment is not mdr-reportable (as no excessive manipulation was required).The exposed spring/possible pebax crack is mdr-reportable.

Manufacturer Narrative

On 30-aug-2021, bwi received additional information regarding the event.The curve of the catheter was stuck/jammed in a full deflected position.The knob/piston was not unable to be turned and/or pushed up and down.There was difficulty in removing the catheter.No ring, electrode or other physical damage observed at the distal end of the catheter but it felt the spring felt kind of soft.The sheath used was 9fr, short sheath, terumo.The catheter pebax was not physically damaged.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

On 6-aug-2021, the bwi product analysis lab received the device for evaluation.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.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

On 27-sep-2021, the product investigation was completed.It was reported that an unknown patient underwent an unknown ablation procedure with thermocool® smart touch® sf bi-directional navigation catheter.The ablation catheters get stuck.When it was going to go to the trans aortic for ablation while mapping the lateral side of the mitral valve.The ablation catheters got stuck, when the physician takes it out, the spring part of the stsf is very easy to remove.The catheter replacement was performed as a precaution, and the procedure was successfully completed.It was confirmed that there was no problem with the patient's echo, etc.The procedure was completed without patient's consequence.Device evaluation details: visual analysis of the returned catheter revealed that the pebax had a hole on the surface of the smart touch bidirectional sf.Deflection testing was performed, in accordance with bwi procedures.The deflection mechanism pass the test, the curve met the specification.The deflection mechanism works good and no anomalies were noticed.Outer diameter of polyurethane margins was measured in accordance with bwi procedures.The catheter was working correctly, and the device was found within specifications.A manufacturing record evaluation was performed for the finished device 30479657m number, and no internal actions related to the reported complaint condition were identified.It should be noted that product failure is multifactorial.The instruction for use contains the following information: in order to prevent damage to the catheter tip, use the insertion tube supplied with the catheter to advance or retract the catheter through the hemostasis valve of the sheath.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: 12247156
• MDR Text Key: 264960337
• Report Number: 2029046-2021-01219
• 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,Followup
• Report Date: 10/15/2021

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: 01/06/2022
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30479657M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2021
• Initial Date Manufacturer Received: 07/07/2021
• Initial Date FDA Received: 07/29/2021
• Supplement Dates Manufacturer Received: 08/06/2021; 08/30/2021; 09/27/2021
• Supplement Dates FDA Received: 08/24/2021; 09/20/2021; 10/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1