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

Catalog Number	INT6F07C1
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	12/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The physician intended to use an intrakit access kit.There was no damage noted to the intrakit packaging.The device was removed from packaging per ifu with no issues.The device was inspected with no issues and prepped per ifu with no issues.The device was properly hydrated.A proximal right radial approach was used, in a non-tortuous and non-calcified vessel.No resistance was encountered when advancing the device.No excessive force was used during insertion.The hub of the dilator detached on removal from the introducer sheath.The entire sheath was removed.No components remain in the patient.No patient injury reported.
Additional Manufacturer Narrative
Product analysis summary: received for analysis was an intrakit introducer sheath, dilator and guide wire in a competitor pouch.The 6f dilator is in two pieces, hub separated from dilator sheath confirming the reported event.The introducer is bloody and the wire is coil wrapped and kinked.Image review: photos were provided by the customer.The first photo shows the product label.The second photo shows a 6f introducer and a guide wire inside a pouch, and a 6f dilator in two pieces.The hub separated from dilator sheath.The photos are consistent with the return condition.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: 7178508
• Report Number: 1220452-2018-00003
• Device Sequence Number: 987427
• Product Code: DYB
• UDI-Device Identifier: 20643169712199
• UDI-Public: 20643169712199
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 02/28/2018

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: 10/15/2019
• Device Catalogue Number: INT6F07C1
• Device Lot Number: 2016105140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2018
• Initial Date Received by Manufacturer: 12/15/2017
• Supplement Date Received by Manufacturer: 02/01/2018
• Initial Report FDA Received Date: 01/10/2018
• Supplement Report FDA Received Date: 02/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 104