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

Catalog Number INT6F11C1

Device Problem Detachment of Device or Device Component (2907)

Patient Problems No Consequences Or Impact To Patient (2199); Patient Problem/Medical Problem (2688)

Event Date 09/26/2017

Event Type  Injury  

Event 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.

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
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• Manufacturer (Section G): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 6999297
• MDR Text Key: 91454763
• Report Number: 1220452-2017-00110
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 20643169712236
• UDI-Public: 20643169712236
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K162097
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/17/2019
• Device Catalogue Number: INT6F11C1
• Device Lot Number: 2016105166
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/06/2017
• Date Device Manufactured: 10/17/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention