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

Model Number	STJ408310
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not yet been returned to the manufacturer at the time of this report.A supplemental form will be sent once the evaluation is completed if the device is returned.The device history report was reviewed and no discrepancies were found.
Event or Problem Description
It was reported that the valve cap broke off while in use.Photos reveal no part left inside patient.No harm or consequence to the patient.
Additional Manufacturer Narrative
The customer returned 1 stj408310 sheath reporting that, "the new cap we put on came apart." the customer provided a photo of the cap no longer in place on the complaint device with the top portion of the seal sticking to the cap.The device was examined under magnification and no trace of adhesive was found on either the cap or the introducer hub.

• Common Device Name: AGILIS SHEATH
• Manufacturer (Section D): STERILMED, INC.; 11400 73rd ave n; maple grove MN
• MDR Report Key: 6570858
• Report Number: 2134070-2017-00010
• Device Sequence Number: 640554
• Product Code: DYB
• 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
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2017

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 Expiration Date: 01/01/2018
• Device Model Number: STJ408310
• Device Catalogue Number: STJ408310
• Device Lot Number: 1968801
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/16/2017
• Supplement Report FDA Received Date: 06/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1