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	11/09/2017
Type of Reportable Event	Malfunction
Event or Problem Description
The physician intended to use a intrakit 6f device.No damage was noted to the intrakit 6f packaging.The device was removed from packaging per ifu with no issues noted.The device was inspected and prepped with no issues noted.The device was properly hydrated.The device was placed in the radial artery.No resistance was noted during insertion, and no force was applied.Attention was given when inserting the dilator in the sheath.After insertion of the device in the patient, when removing the dilator, the hub broke off.The hub detached during removal of the dilator from the introducer.No intervention was required - the physician continued with the procedure as the dilator was already out of the sheath, and the sheath was placed correctly.No resistance was noted when removing the introducer from the sheath.The device was not bent excessively prior to the detachment.No injury was reported.
Additional Manufacturer Narrative
Photo analysis: the photos provided by the customer shows the dilator in a ziplock bag in two pieces, hub separated from dilator sheath.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Product analysis: as received the dilator is in two pieces, the hub separated from the dilator sheath.The 6f intrakit introducer sheath tip id meets specification.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: 7086250
• Report Number: 1220452-2017-00124
• Device Sequence Number: 1799056
• Product Code: DYB
• UDI-Device Identifier: 20643169712236
• UDI-Public: 20643169712236
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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): 03/14/2018

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: 03/13/2020
• Device Catalogue Number: INT6F11C1
• Device Lot Number: 2017035198
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2017
• Initial Date Received by Manufacturer: 11/09/2017
• Supplement Date Received by Manufacturer: 12/04/2017; 02/13/2018
• Initial Report FDA Received Date: 12/06/2017
• Supplement Report FDA Received Date: 12/14/2017; 03/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1