MAUDE Adverse Event Report: ARGON MEDICAL DEVICES INC. 7F MICRO INTRODUCER SET; GUIDEWIRE

Catalog Number MIS-7F07

Device Problem Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/24/2016

Event Type  malfunction  

Manufacturer Narrative

There is no sample or photo available, but the lot number was provided.A review of the device history records and inspection records was conducted, and no similar concerns were found.Since the sample is not available for return and there were no concerns noted in the manufacturing documentation, the issue cannot be confirmed, and a root cause and corrective action cannot be determined and implemented at this time.

Event Description

Customer reported that they used a 018 guide wire and the ifu was followed on a perforator vein.The needle was removed and the perforator catheter was advanced over the wire.The wire was removed without resistance.The ablation was then performed and the temperature was reached and completed and the catheter was removed.Final ultrasound demonstrated a linear echogenic object within the vein.The wire was evaluated and was seen to have 4cm missing of the distal tip which remains in the vein.One segment was treated and it is unknown if the vein closed.Patient is stable at this time.

• Brand Name: 7F MICRO INTRODUCER SET
• Type of Device: GUIDEWIRE
• 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: 6081192
• MDR Text Key: 59602809
• Report Number: 1625425-2016-00080
• Device Sequence Number: 1
• Product Code: DRE
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K780126
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 09/01/2020
• Device Catalogue Number: MIS-7F07
• Device Lot Number: 11123265
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/10/2016
• Initial Date FDA Received: 11/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/21/2015
• 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
• Patient Outcome(s): Required Intervention