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	08/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Report originally submitted on (b)(6) 2017 during an outage with fda.Resubmitting as acknowledgments were not received.
Event or Problem Description
The physician was using an intrakit device, right arm access was applied.It is reported that when removing the dilator from the sheath while in the patient, the hub of the dilator broke off.The wire was removed separately, not at the same time as the dilator.The physician had to pull device out and press on the artery.No injury reported.
Additional Manufacturer Narrative
Product analysis summary: visual inspection on the introducer sheath exhibited no noticeable defects.The broken dilator tubing and the hub were taped to the pouch as received.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.Additional information: the physician took the sheath out in one piece.No instruments were used to remove the sheath.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: 6961776
• Report Number: 1220452-2017-00095
• Device Sequence Number: 719081
• 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): 01/05/2018

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: 10/17/2019
• Device Catalogue Number: INT6F11C1
• Device Lot Number: 2016105166
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2017
• Initial Date Received by Manufacturer: 08/18/2017
• Supplement Date Received by Manufacturer: 12/07/2017
• Initial Report FDA Received Date: 10/19/2017
• Supplement Report FDA Received Date: 01/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1