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

Catalog Number	INT6F11C2
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	11/15/2017
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 a 6f intrakit device.There was no damage to the 6f intrakit packaging.The device was removed from packaging per ifu with no issues noted.The device was inspected with no issues.The device was prepped and hydrated per ifu with no issues.During insertion into the patient's radial artery, the hub of the dilator broke.The dilator was stuck inside the sheath.The sheath and part of the dilator that remained inside the sheath was completely removed without the use of any additional equipment.No resistance was encountered when inserting the dilator into the sheath during prep.No resistance was encountered when advancing the device, and no force was used.The device was not bent excessively prior to the detachment.The physician switched the hand of the patient for pci.No injury was reported.
Additional Manufacturer Narrative
Product analysis summary: received for analysis was one bloody int6f11c1 6f intrakit introducer.Visual inspection on the introducer sheath exhibited no noticeable defects.The broken dilator tubing was bent approximately 8mm from the break.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 sheath met specifications.Photo evaluation summary: one photo was received which matched 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: 7104225
• Report Number: 1220452-2017-00129
• Device Sequence Number: 1483086
• Product Code: DYB
• UDI-Device Identifier: 20643169712267
• UDI-Public: 20643169712267
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• 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): 01/09/2018

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: 10/19/2019
• Device Catalogue Number: INT6F11C2
• Device Lot Number: 2016105180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2017
• Initial Date Received by Manufacturer: 11/15/2017
• Supplement Date Received by Manufacturer: 12/11/2017
• Initial Report FDA Received Date: 12/11/2017
• Supplement Report FDA Received Date: 01/09/2018
• 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