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	Patient Problem/Medical Problem (2688)
Date of Event	06/15/2017
Type of Reportable Event	Serious Injury
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 was attempting to use an intrakit introducer during a procedure using a radial approach.No issues were noted during prep.No abnormalities were reported in relation to anatomy.During the procedure, it is reported that while tilting the dilator, the hub broke off when trying to remove it from the sheath.No excessive force was used.Forceps were then used to remove the rest of the dilator.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: 6731633
• Report Number: 1220452-2017-00068
• Device Sequence Number: 13658552
• Product Code: DYB
• UDI-Device Identifier: 20643169712236
• UDI-Public: 20643169712236
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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?: Yes
• 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?: No
• Initial Date Received by Manufacturer: 06/21/2017
• Supplement Date Received by Manufacturer: 09/13/2017
• Initial Report FDA Received Date: 07/21/2017
• Supplement Report FDA Received Date: 10/11/2017
• 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