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

Catalog Number	INT6F11C1
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	11/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The introducer sheath was not returned.The dilator tubing was broken at the edge of the hub.Measurements for outer and inner diameter of the dilator met specification.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
There were no issues noted with the intrakit packaging.The device was removed from packaging per ifu.The device was inspected with no issues.The device was prepped and properly hydrated per ifu.No resistance was encountered when advancing the device.No excessive force was used during insertion.The dilator hub detached while in the patient¿s proximal right radial artery.The remaining part was pulled out.No injury reported.

• Brand Name: INTRAKIT
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• MDR Report Key: 7126198
• Report Number: 1220452-2017-00137
• Device Sequence Number: 1423226
• Product Code: DYB
• UDI-Device Identifier: 20643169712236
• UDI-Public: 20643169712236
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• 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
• Report Date (Section B): 12/18/2017

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: 09/08/2019
• Device Catalogue Number: INT6F11C1
• Device Lot Number: 2016095069
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2017
• Initial Report FDA Received Date: 12/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 80