MAUDE Adverse Event Report: ARGON MEDICAL DEVICES MICRO INTRODUCER SHEATH SET 7F X 11CM VNUS; CLOSUREFAST

Model Number	MIS-7F11
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for evaluation.A follow-up report will be provided once the investigation is complete.
Event or Problem Description
It was reported that the physician was attempting to use a micro introducer sheath.The lumen was flushed prior to use.The device was prepped as per ifu.It was reported upon close inspection through the bio hazard packet, it was observed that the dilator was cleanly separated from the hub indicating the separation was not stress or strain induced.The customer stated, upon attempting to unfasten the dilator from the 7f introducer, the hub separated from the dilator, leaving the dilator inside the sheath, which was inside the patient's vein.The customer stated they had to secure a mosquito forceps to grasp the broken section of the dilator and could hardly grasp the dilator.The customer stated, had they not been able to grab the dilator with the forceps, it could have had serious patient safety issues.No patient injury reported for this event.
Additional Manufacturer Narrative
H3 other text: placeholder.
Event or Problem Description
Follow up.

• Brand Name: MICRO INTRODUCER SHEATH SET 7F X 11CM VNUS
• Common Device Name: CLOSUREFAST
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX
• MDR Report Key: 11007944
• Report Number: 1625425-2020-00791
• Device Sequence Number: 13620154
• Product Code: DRE
• UDI-Device Identifier: 10884521140356
• UDI-Public: 10884521140356
• Combination Product (Y/N): N
• Initial Reporter State: FL
• PMA/510(K) Number: K780126
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2020

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
• Operator of Device: Health Professional
• Device Model Number: MIS-7F11
• Device Catalogue Number: MIS-7F11
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 12/10/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/15/2020
• Supplement Report FDA Received Date: 01/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other