MAUDE Adverse Event Report: ARGON MEDICAL DEVICES, INC. PCI 5 KIT 7F

Catalog Number 496183

Device Problems Leak/Splash (1354); Occlusion Within Device (1423)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/21/2016

Event Type  malfunction  

Manufacturer Narrative

No patient injury was noted.A review of the dhrs for the package lot and assembly lot(catheter) were conducted and no discrepancies were noted.The inspection records were reviewed as part of the applicable dhr reviews and no discrepancies were noted.The samples were returned with the dilator in-dwelling and after the sterilization process the valves were "set" which makes it difficult to accurately verify the complaint.The complaint sample was still examined and some leakage was noted at 6 psi.However,with the gasket in a set condition, and not sealing as required there is no way to definitely validate the leakage.The ifu states that rapid withdrawal of the catheter or dilator through the hemostasis valve may cause misalignment of the valve gasket assembly, causing bleedback through the valve.Should this occur, resetting of the valve may be accomplished by gentle pressure into the valve with the tip of a dilator or catheter.

Event Description

Valves leak and forming clot that could be re introduced into the body and cause serious harm.

• Brand Name: PCI 5 KIT 7F
• Type of Device: PCI 5 KIT 7F
• Manufacturer (Section D): ARGON MEDICAL DEVICES, INC.; 1445 flat creek road; athens TX 75751
• Manufacturer (Section G): ARGON MEDICAL DEVICES, INC.
• Manufacturer Contact: gail smith ; 1445 flat creek road; athens, TX 75751 ; 2144368995
• MDR Report Key: 5577589
• MDR Text Key: 43297299
• Report Number: 1625425-2016-00012
• Device Sequence Number: 1
• Product Code: DRE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K780126
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/13/2016

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: Other
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: 496183
• Device Lot Number: 11123849
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/22/2016
• Initial Date FDA Received: 04/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1