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  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

The physician intended to use an intrakit introducer device.There was no damage to the intrakit packaging and the device was removed from packaging per ifu with no issues.The device was inspected and prepped per ifu with no issues.The device was properly hydrated.Excessive force was not used during insertion/ delivery.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 physician attempted to remove the dilator in the usual manner from the sheath whilst it was inserted in the patient's wrist.As the physician went to remove the dilator, the dilator hub broke cleanly off.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.The physician had to rewire through the broken dilator which was stuck inside the sheath.Once wire was placed, the faulty sheath and dilator were removed together and a new sheath opened and used.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Product analysis: received for analysis was a int6f11c1 6f intrakit introducer with original packaging.The dilator tubing was broken at the edge of the hub.Visual inspection on the introducer sheath exhibited no noticeable defects.As received the broken dilator was bloody and engaged to the introducer sheath.After cleaning the devices, the tubing was disengaged from the sheath.The tubing and sheath were wetted and inserted into the lumen of the returned sheath; normal resistance was noted when passing the tip of the sheath was inserted.Actual physical measurements for outer and inner diameter of the dilator met specification.Introducer sheath measurements met specification.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: 6996618
• MDR Text Key: 91333709
• Report Number: 1220452-2017-00109
• 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,Followup
• Report Date: 03/21/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 10/17/2019
• Device Catalogue Number: INT6F11C1
• Device Lot Number: 2016105166
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/06/2017
• Initial Date FDA Received: 11/02/2017
• Supplement Dates Manufacturer Received: 11/06/2017; 02/20/2018
• Supplement Dates FDA Received: 12/01/2017; 03/21/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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