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

Catalog Number	INT5F11C2
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	09/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.The sheath and dilator of the intrakit introducer kit were prepared as advised.It was inserted, and when the dilator was due to be separated from the sheath to be removed, the hub of the dilator fell off.The physician was able to remove the remaining part of the dilator with a clip.The physician did not have any concerns about the sheath.The physician left the sheath in the patient's radial artery and continued with the case.The physician did not feel that the sheath was damaged and was happy to carry on.
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: 7006040
• Report Number: 1220452-2017-00113
• Device Sequence Number: 11200007
• Product Code: DYB
• UDI-Device Identifier: 20643169712120
• UDI-Public: 20643169712120
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 02/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/13/2020
• Device Catalogue Number: INT5F11C2
• Device Lot Number: 2017025146
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/09/2017
• Supplement Date Received by Manufacturer: 12/04/2017
• Initial Report FDA Received Date: 11/07/2017
• Supplement Report FDA Received Date: 02/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention