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

Catalog Number	INT6F11A3
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis: the device was bloody indicating use.Visual inspection on the introducer sheaths had no noticeable defects.The broken dilator tubing was engaged to the sheath and the remaining part of the tubing was still engaged to the hub.The dilator tubing was broken at the edge of the hub.Actual physical measurements for outer and inner diameter of the dilator met specification indicating wall thickness is not a contributor to the event.Actual physical measurement of the introducer sheaths met specifications.(b)(4).
Event or Problem Description
The physician intended to use a 6f intrakit introducer.No damage was noted to the packaging of the device.The device was removed from packaging per ifu.No issues were noted when inspected on removal from packaging.The device was prepped per ifu.The device was properly hydrated.No resistance was encountered during advancement.Excessive force was not applied.It is reported that as the physician attempted to remove the dilator from the sheath the hub was separated from 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: 6471161
• Report Number: 1220452-2017-00026
• Device Sequence Number: 371544
• Product Code: DYB
• UDI-Device Identifier: 20643169712274
• UDI-Public: 20643169712274
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K162097
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2017

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: 10/13/2019
• Device Catalogue Number: INT6F11A3
• Device Lot Number: 2016105124
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2017
• Initial Date Received by Manufacturer: 03/08/2017
• Supplement Date Received by Manufacturer: 07/07/2017
• Initial Report FDA Received Date: 04/07/2017
• Supplement Report FDA Received Date: 08/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1