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	08/16/2017
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 device.No damage noted to intrakit packaging.The device was removed from packaging per ifu, inspected and prepped per ifu with no issues.The device was properly hydrated.The dilator hub broke when disengaging from the sheath however did not totally detach.The sheath was removed due to the dilator issue.The wire that came with the kit had been removed before the hub broke.No resistance advancing the device, excessive force was not used.Right arm radial access used.No patient injury reported.
Additional Manufacturer Narrative
Product analysis: photographs provided by the account show the dilator sheath broke at the hub.This is consistent with the return device.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Product analysis summary: received for analysis was one 6f intrakit dilator with original packaging.As received, the dilator sheath is broken at the hub, with a small amount of material still attached.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: 6868055
• Report Number: 1220452-2017-00094
• Device Sequence Number: 873519
• Product Code: DYB
• UDI-Device Identifier: 20643169712236
• UDI-Public: 20643169712236
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,Followup
• Report Date (Section B): 12/08/2017

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: 09/27/2019
• Device Catalogue Number: INT6F11C1
• Device Lot Number: 2016095224
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2017
• Initial Date Received by Manufacturer: 08/16/2017
• Supplement Date Received by Manufacturer: 09/29/2017; 11/16/2017
• Initial Report FDA Received Date: 09/15/2017
• Supplement Report FDA Received Date: 10/27/2017; 12/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1