MAUDE Adverse Event Report: ARGON MEDICAL DEVICES CLOSUREFAST MICRO INTRODUCER SHEATH SET 7FR/CH (2.3MM) X 7CM

Model Number MIS-7F07

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/30/2022

Event Type  Injury  

Manufacturer Narrative

The sample is indicated as available for return.As of the date of this report, the sample has not been returned.A follow-up report will be provided once the device has been received and reviewed.

Event Description

Physician attempted to use a micro introducer kit during treatment of the patient¿s great saphenous vein (gsv).The lumen was flushed prior to use.The ifu (instruction for use) was followed during preparation, procedure, post-procedure.Tumescent infiltration was utilized.Local anesthesia was used.Hand compression was used.It is reported the guide wire broke off at the tip of about 1 cm in length and remained in vein when wire was pulled out.Physician had to do an additional stablectomy to cut that portion of the vein out and were able to retrieve the broken segment.The device was used successfully.All pieces were accounted for.11 segments were treated and vein is reported to have closed successfully.No further patient injury reported.

• Brand Name: CLOSUREFAST MICRO INTRODUCER SHEATH SET 7FR/CH (2.3MM) X 7CM
• Type of Device: CLOSUREFAST MICRO INTRODUCER SHEATH SET
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX 75751
• Manufacturer Contact: elnaz rahman ; 1445 flat creek rd; athens, TX 75751 ; 9036759321
• MDR Report Key: 15446790
• MDR Text Key: 300153014
• Report Number: 0001625425-2022-01096
• Device Sequence Number: 1
• Product Code: DRE
• UDI-Device Identifier: 10884521140295
• UDI-Public: 10884521140295
• 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: Health Professional,User Facility
• Reporter Occupation: Physician Assistant
• Type of Report: Initial
• Report Date: 09/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MIS-7F07
• Device Lot Number: 11405902
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/07/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention