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

Model Number MIS-7F07

Device Problem Difficult to Advance (2920)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 12/01/2023

Event Type  Injury  

Manufacturer Narrative

According to the product experience report, there was no sample to be returned.Additionally, no photographic or visual evidence of any kind was provided which would have allowed for the allegation to be reviewed.Without such evidence, this complaint could not be confirmed and determining a definite root cause and corrective action is not possible.If the sample is returned at a future date, a follow-up report will be submitted.

Event Description

A micro introducer sheath was to be used during treatment of the great saphenous vein (gsv).The physician noticed 5 sheaths that were extremely difficult to push the catheter through the sheath.The ifu was followed.Physician concerned that the catheter could kink or break off, once forced catheter through and a "pop" was felt and an abnormal amount of blood loss occurred through the valve of the sheath.The procedure was finished using the sheath but the blood loss was not normal.The device is not available for return as it was discarded.

• Brand Name: CLOSUREFAST MICRO INTRODUCER SHEATH SET 7FR/CH (2.3MM) X 7CM
• Type of Device: CLOSUREFAST MICRO INTRODUCER
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX 75751
• Manufacturer Contact: kelly mayer ; 1445 flat creek rd; athens, TX 75751 ; 9036759321
• MDR Report Key: 18464928
• MDR Text Key: 332317225
• Report Number: 0001625425-2024-00919
• Device Sequence Number: 1
• Product Code: DRE
• UDI-Device Identifier: 00886333227532
• UDI-Public: 886333227532
• 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,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2024
• 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: 11497809
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/19/2023
• 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): Other