MAUDE Adverse Event Report: MEDTRONIC, INC INPUT PS INTRODUCER SHEATH; INTRODUCER, CATHETER

Model Number	070011
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/30/2019
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 an expired input introducer kit was opened at the account and used in a patient.The device was being used for venous access.It was reported that there was no tortuosity or calcification.There were no abnormalities reported in relation to the patient anatomy.There was no damage noted to the packaging.The device was removed from the packaging per the ifu with no issues identified.The device was inspected with no issues.The device was prepped per the ifu with no issues identified.The device was properly hydrated.Resistance was not encountered when advancing the device and excessive force was not used during insertion/delivery.No patient injury was reported.

• Brand Name: INPUT PS INTRODUCER SHEATH
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• MDR Report Key: 8639803
• Report Number: 1220452-2019-00069
• Device Sequence Number: 2354067
• Product Code: DYB
• UDI-Device Identifier: 20643169014583
• UDI-Public: 20643169014583
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K132617
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/24/2019

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: 01/17/2019
• Device Model Number: 070011
• Device Catalogue Number: 070011
• Device Lot Number: 50961779
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2019
• Initial Report FDA Received Date: 05/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1