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
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 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.
Additional 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.
Additional 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
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• MDR Report Key: 6996618
• Report Number: 1220452-2017-00109
• Device Sequence Number: 19206518
• 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,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 10/06/2017
• Supplement Date Received by Manufacturer: 11/06/2017; 02/20/2018
• Initial Report FDA Received Date: 11/02/2017
• Supplement Report FDA Received Date: 12/01/2017; 03/21/2018
• 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