MAUDE Adverse Event Report: MEDTRONIC, INC. OPTISEAL; INTRODUCER, CATHETER

Model Number	1000093004
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/25/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that intra-operatively, the introducer valve had blood slowly egressing.The introducer remained in use for the procedure.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Regulatory reporting is the responsibility of the manufacturer; this report was unnecessarily submitted.If information is provided in the future, a supplemental report will be issued.

• Brand Name: OPTISEAL
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• MDR Report Key: 8073923
• Report Number: 2182208-2018-02082
• Device Sequence Number: 2364436
• Product Code: DYB
• UDI-Device Identifier: 00821329600227
• UDI-Public: 00821329600227
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: OEM-RESP
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2019

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: 07/09/2020
• Device Model Number: 1000093004
• Device Catalogue Number: 1000093004
• Device Lot Number: W4392170
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/25/2018
• Supplement Date Received by Manufacturer: 01/18/2019
• Initial Report FDA Received Date: 11/15/2018
• Supplement Report FDA Received Date: 01/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 48 YR