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

Model Number D134805

Device Problems Material Twisted/Bent (2981); Mechanical Jam (2983)

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

Event Date 06/21/2021

Event Type  malfunction  

Manufacturer Narrative

The biosense webster, inc.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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent an ischemic ventricular tachycardia (isvt) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter (stsf) and a deflection stuck issue occurred.The stsf catheter was discovered to have visible damage after it was inserted into the body.The catheter¿s "wire was kinked" and so it was stuck on a curved position at maximum deflection.It was reported that the doctor quickly pulled it and it was bagged right away and so it was uncertain whether the knob/piston was unable to be turned and/or pushed up and down.There was no difficulty in removing the catheter.The damage did not result in wires being exposed or in any lifted or sharp rings.There was no resistance nor difficulty during the insertion or removal of the catheter.The issue was found mid-way down from the distal end of the catheter and it was not pre-shaped.The catheter was replaced, and the issue was resolved.The procedure continued successfully.No adverse patient consequences were reported.

Manufacturer Narrative

It was reported that a patient underwent an ischemic ventricular tachycardia (isvt) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter (stsf) and a deflection stuck issue occurred.The stsf catheter was discovered to have visible damage after it was inserted into the body.The catheter¿s "wire was kinked" and so it was stuck on a curved position at maximum deflection.It was reported that the doctor quickly pulled it and it was bagged right away and so it was uncertain whether the knob/piston was unable to be turned and/or pushed up and down.There was no difficulty in removing the catheter.The damage did not result in wires being exposed or in any lifted or sharp rings.There was no resistance nor difficulty during the insertion or removal of the catheter.The issue was found mid-way down from the distal end of the catheter and it was not pre-shaped.The catheter was replaced, and the issue was resolved.The procedure continued successfully.No adverse patient consequences were reported.The bent tip has been assessed as not mdr reportable.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.The deflection stuck issue has been assessed as mdr reportable as malfunction of the device can potentially be related to serious injury.Device evaluation details: the device evaluation was completed on 10-aug-2021.Visual analysis of the returned sample revealed that the tip was bent on the thermocool® smart touch® sf bi-directional navigation catheter.The deflection mechanism was not found stuck.Deflection test was performed and it was found within specifications, the catheter was deflecting correctly.All units are inspected prior to leaving the facility.There are functional tests and inspections at control points based on the process flow diagram (pfd) per its part number to avoid this type of damage from leaving the facility.At this time, it is not possible to determine the root cause of bent tip, however based on the information provided, the condition reported have origin in some place external to the manufacturing environment.A manufacturing record evaluation was performed for the finished device 30550754m number, and no internal action was found during the review.As part of biosense webster inc¿s quality process, all devices are manufactured, inspected, and released to approved specifications.The instructions for use states that sterile packaging and catheter should be inspected prior to use.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: 12187078
• MDR Text Key: 262176609
• Report Number: 2029046-2021-01135
• 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: 06/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/27/2022
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30550754M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2021
• Date Manufacturer Received: 08/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN BRAND CATHETER; UNKNOWN BRAND SHEATH (POSSIBLY PINNACLE 9FR); UNKNOWN BRAND CATHETER; UNKNOWN BRAND SHEATH (POSSIBLY PINNACLE 9FR)