MAUDE Adverse Event Report: ARGON MEDICAL DEVICES MICRO INTRODUCER SHEATH SET 7F X 7CM VNUS; CLOSUREFAST

Model Number MIS-7F07

Device Problem Break (1069)

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

Event Date 08/28/2020

Event Type  malfunction  

Manufacturer Narrative

The device was indicated as unavailable for evaluation.However, based on the photo provided, the core wire appears to have failed or fractured about 1/2 cm proximal from the coil, confirming the complaint.The coil appears intact with only bending damage, probably from the retrieval procedure, but no distal tip weld failures or coil detachment.A failure of the core at this point is unusual because it does not see much tensile or bending load during use.It is possible it was a defect in the core wire metal structure but without the physical sample returned and the fracture area on the photo covered with blood, the root cause cannot be conclusively determined.

Event Description

Physician intended to use a 7fr micro introducer sheath during an rfa procedure to treat the patient¿s short saphenous vein (ssv).Ifu was followed.No visible damage was noted to the micro introducer sheath.It is reported the rfa procedure was successfully completed and the vessel was closed but following the procedure of the right small saphenous vein, it was noted that a small piece of the 0.018 wire from the mis7f-07 sheath was missing from the wire (floppy tip) in the patients small saphenous vein.The physician immediately attempted to identify under ultrasound, but it was not present in the patient¿s vein.Physician could not determine if the wire was located in the patient¿s soft tissue as the wire tip is extremely small.Therefore, the physician advised determining whether there was any piece of the wire or foreign body present in the patient¿s soft tissue of the right calf.The piece of wire was retrieved from the patient the same day.Under fluoroscopy of the right leg, a foreign body which appeared of a piece of wire was identified in the patient¿s right calf.With a 1-2 cm incision in the right calf over the foreign body under fluoroscopy physician dissected the small saphenous vein and isolated it, then dissected the gastrocnemius muscle and identified the foreign body was successfully removed in its entirety.Repeat fluoroscopy demonstrated the foreign body was successfully removed in its entirety.The incision was irrigated with antibiotic solution and meticulous haemostasis was achieved and the incision was closed.The patient tolerated the procedure without difficulty or complication and was taken to the recovery room in stable condition.No further injury reported.

• Brand Name: MICRO INTRODUCER SHEATH SET 7F X 7CM VNUS
• Type of Device: CLOSUREFAST
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX
• Manufacturer Contact: gina liu ; 1445 flat creek rd, athens, tx 75751
• MDR Report Key: 10651039
• MDR Text Key: 212110405
• Report Number: 1625425-2020-00582
• Device Sequence Number: 1
• Product Code: PNC
• UDI-Device Identifier: 10884521140295
• UDI-Public: 10884521140295
• Combination Product (y/n): N
• PMA/PMN Number: K780126
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 10/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2024
• Device Model Number: MIS-7F07
• Device Catalogue Number: MIS-7F07
• Device Lot Number: 11257724
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/30/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other