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

Catalog Number	INT6F11C2
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	11/08/2017
Type of Reportable Event	Serious Injury
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 device during a procedure.There was no damage noted to packaging of the 6f intrakit.The device was removed from packaging per ifu and inspected with no issues noted.The device was prepped per ifu with no issues noted.The device was properly hydrated.No resistance was encountered during insertion and no force was applied.Leakage of the sheath through the hub occurred during insertion, with a lot of blood loss.There was no issue with the dilator.No special intervention was required.The physician replaced the sheath with a non-medtronic sheath.The patient is alive with no injury reported.The age of the patient is approximate.
Additional Manufacturer Narrative
Photographic analysis: the photograph received shows an opening in the "gland" of the device that would allow blood loss.This is consistent with the returned sample.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Product analysis summary: as received the guide wire is engaged in the dilator.The introducer was received bloody and the hemostasis valve inside the hub is dislodged leaving an opening for blood loss.With the naked eye an opening can be seen in the valve.Back lit shows the valve is dislodged within the hub leaving a gap between the valve and hub.The hub cap was removed to reveal the dislodged gland.The gland was removed and inspected.The gland appears to be intact, the slit is present on both sides.The dilator from the kit was inserted into the gland.The dilator entered the center of the slit as expected.The inside of the hub and shelf the gland sits on appears without defect.The hub cap appears with out issue.The gland was placed back in the hub and appears to seat without issue.If information is provided in the future, a supplemental report will be issued.
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: 7086049
• Report Number: 1220452-2017-00123
• Device Sequence Number: 1079991
• Product Code: DYB
• UDI-Device Identifier: 20643169712267
• UDI-Public: 20643169712267
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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,Followup,Followup
• Report Date (Section B): 05/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/21/2020
• Device Catalogue Number: INT6F11C2
• Device Lot Number: 2017035273
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2017
• Initial Date Received by Manufacturer: 11/08/2017
• Supplement Date Received by Manufacturer: 02/13/2018; 03/16/2018; 04/26/2018
• Initial Report FDA Received Date: 12/06/2017
• Supplement Report FDA Received Date: 03/14/2018; 04/13/2018; 05/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Weight: 75