MAUDE Adverse Event Report: MEDTRONIC, INC INTRAKIT; INTRODUCER, CATHETER

Catalog Number	INT6F23C4
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/10/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The physician intended to use an intrakit access kit.There was no damage noted to packaging.The device was removed from the packaging per the ifu with no issues.Device was inspected and prepped with no issues.The device was properly hydrated.It is reported that the dilator green hub detached from its sheath, a radial approach was used.No resistance was encountered when inserting the dilator into the sheath during prep.No excessive force used.No resistance noted when attempting to remove the introducer from the sheath.No patient injury reported.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: INTRAKIT
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• MDR Report Key: 6776864
• Report Number: 1220452-2017-00071
• Device Sequence Number: 16544681
• Product Code: DYB
• UDI-Device Identifier: 20643169712298
• UDI-Public: 20643169712298
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K162097
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2017

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: 09/30/2019
• Device Catalogue Number: INT6F23C4
• Device Lot Number: 2016095262
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/11/2017
• Supplement Date Received by Manufacturer: 09/13/2017
• Initial Report FDA Received Date: 08/09/2017
• Supplement Report FDA Received Date: 10/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1