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	07/25/2017
Type of Reportable Event	Malfunction
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 intended to use an intrakit transradial access kit.There was no damage noted to packaging.The device was removed from the packaging per ifu with no issues.The device was inspected with no issues.The device was prepped per ifu with no issues.The device was properly hydrated.The access site was the right radial artery.Excessive force was used during insertion.Once in position, the required force was used to disengage the dilator from the sheath.The physician pulled back the wire and dilator but realised that the hub had snapped off the dilator leaving the blue dilator stuck inside the sheath inside the patients right radial artery.The dr.Then had to re-wire the broken dilator stuck inside sheath to maintain radial access and then remove the sheath and dilator and replace with a new sheath and dilator.No injury occurred to the patient.
Additional Manufacturer Narrative
Product analysis: visual inspection on the returned intra-kit 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.Actual physical measurement of the introducer sheaths met specifications.Photos of the damaged intra-kit received from the account match that of the returned device.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: 6816420
• Report Number: 1220452-2017-00085
• Device Sequence Number: 10796151
• 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,Followup
• Report Date (Section B): 09/15/2017

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: 09/27/2019
• Device Catalogue Number: INT6F11C1
• Device Lot Number: 2016095224
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2017
• Initial Date Received by Manufacturer: 07/26/2017
• Supplement Date Received by Manufacturer: 09/15/2017
• Initial Report FDA Received Date: 08/24/2017
• Supplement Report FDA Received Date: 10/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1