MAUDE Adverse Event Report: KDL MEDICAL DBA CHASE MEDICAL TRIPOD HEART STABILIZER NYLON BLOWER/OCCLUDER; STABILIZER, HEART

Model Number	STO-3BC4S
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported - one of the stabilizer feet came loose from the barrel during the procedure.Stabilizer was removed and a replacement device was used to complete the procedure.There was no patient harm reported resulting from this complaint.
Additional Manufacturer Narrative
Reviewed the lot history file for f209016.The work order was for a lot of 5 stabilizers (sto-3bc4s).All required paperwork was present in the file documenting that the stabilizers were manufactured, tested, and inspected per procedure.All units passed the required inspections.The process of attaching the feet to the foot adapters is covered in map-130 (section 4.0).The two-part epoxy mixing, usage and dry time was properly documented using form 123 stabilizer in-process testing and packaging log.The 100% foot bond test was performed and recorded on the form as required.The foot detaching from the foot adapter is a know hazard that is identified in the current risk identification and analysis log for the heart stabilizer.There have been 3 prior ncrs for this defect and no prior complaints.Prior investigation #05-0003 has shown that this is likely caused by inadequate mixing of the two-part epoxy.A new investigation was opened #22-001 related to the most recent ncr 22-005 and concluded that the process for two-part epoxy mixing and use remains effective.Car 22-009 was opened for retraining with all assemblers related to two-part epoxy mixing and usage.Map is being updated to clarify how foot bond test is performed to ensure adequate bonding.

• Brand Name: TRIPOD HEART STABILIZER NYLON BLOWER/OCCLUDER
• Common Device Name: STABILIZER, HEART
• Manufacturer (Section D): KDL MEDICAL DBA CHASE MEDICAL; 885 e. collins blvd.,; suite 110; richardson TX 75081
• Manufacturer (Section G): KDL MEDICAL DBA CHASE MEDICAL; 885 e. collins blvd.,; suite 885; richardson TX 75081
• Manufacturer Contact: jackie lafollette ; 885 e. collins blvd.,; suite 110; richardson, TX 75081 ; 9727837005
• MDR Report Key: 16142179
• Report Number: 1649139-2022-00001
• Device Sequence Number: 7470291
• Product Code: MWS
• UDI-Device Identifier: 00899054002531
• UDI-Public: 00899054002531
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/11/2023

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 Expiration Date: 09/29/2025
• Device Model Number: STO-3BC4S
• Device Catalogue Number: STO-3BC4S
• Device Lot Number: F209016
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/14/2022
• Initial Report FDA Received Date: 01/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown