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	09/06/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis: visual inspection on the introducer sheath exhibited no noticeable defects.The broken dilator tubing was engaged to the sheath and the remaining small 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.
Event or Problem Description
The physician intended to use an intrakit device.No damage was noted to the packaging.The device was removed from packaging per ifu with no issues.The device was prepped per ifu with no issues.The device was properly hydrated.Event through the sheath had been properly hydrated , the consultant found it difficult to insert dilator and sheath into the radial artery.Excessive force was used during insertion.When the consultant bent the dilator at the 30 degree angle and removed the dilator from the sheath, the dilator hub broke off and left the dilator inside the sheath.The sheath had to be removed and replaced with a competitor sheath.No injury caused to patient.

• Brand Name: INTRAKIT
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• MDR Report Key: 6914471
• Report Number: 1220452-2017-00100
• Device Sequence Number: 1090124
• Product Code: DYB
• UDI-Device Identifier: 20643169712236
• UDI-Public: 20643169712236
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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
• Report Date (Section B): 09/06/2017

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: 10/17/2019
• Device Catalogue Number: INT6F11C1
• Device Lot Number: 2016105166
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2017
• Initial Report FDA Received Date: 10/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1