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 Codes	No Consequences Or Impact To Patient (2199); Patient Problem/Medical Problem (2688)
Date of Event	09/26/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
The physician intended to use an intrakit introducer device.There was no damage to packaging of the intrakit introducer.The device was removed from packaging as per ifu and inspected with no issues noted.The device was prepped per ifu with no issues.The device was properly hydrated.Resistance was encountered when the dilator was inserted into the sheath up until the last 1cm- only before the hub was connected did the resistance increase significantly.The dilator hub broke cleanly off the dilator when the physician tried to remove the dilator from the sheath while it was still in the patient's wrist.Excessive force was not used during insertion/ delivery.The device was not bent excessively prior to the detachment.No components remain in the patient.No patient injury reported.The device was replaced with a non mdt device.
Additional Manufacturer Narrative
The dilator remained stuck inside the sheath once the green hub snapped off the blue dilator.The physician had to rewire through the broken dilator which was stuck inside the sheath.Once the wire was placed, the faulty sheath and dilator were removed together and a new sheath was opened and used.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: 6999297
• Report Number: 1220452-2017-00110
• Device Sequence Number: 1005171
• 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): 12/05/2017

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: 10/17/2019
• Device Catalogue Number: INT6F11C1
• Device Lot Number: 2016105166
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/06/2017
• Supplement Date Received by Manufacturer: 11/06/2017
• Initial Report FDA Received Date: 11/03/2017
• Supplement Report FDA Received Date: 12/05/2017
• 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