MAUDE Adverse Event Report: STERILMED, INC.; AGILIS SHEATH

Model Number	STJ408310
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/21/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No device will be returned, it was reported to be accidentally discarded by the facility.The device history report was reviewed and no discrepancies were found.
Event or Problem Description
It was reported that the hub assembly came apart while inside patient.There was no harm or consequence to the patient.No device will be returned, it was accidentally discarded by the facility.

• Common Device Name: AGILIS SHEATH
• Manufacturer (Section D): STERILMED, INC.; 11400 73rd ave n; maple grove MN
• MDR Report Key: 6581264
• Report Number: 2134070-2017-00012
• Device Sequence Number: 97651
• Product Code: PNE
• UDI-Device Identifier: 10888551044929
• UDI-Public: 011088855104492917180109101968801
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 04/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: STJ408310
• Device Catalogue Number: STJ408310
• Device Lot Number: 1968801
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2017
• Initial Report FDA Received Date: 05/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1