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	09/18/2018
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 during use, the hemostasis valve leaked blood, and would not maintain hemostasis without a lead inserted.The valve was not used.No patient complications have been reported as a result of this event.

• 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: 7973457
• Report Number: 2182208-2018-01882
• Device Sequence Number: 11205951
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/17/2018

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2018
• Initial Report FDA Received Date: 10/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 83 YR