MAUDE Adverse Event Report: COOK INC UNKNOWN; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number G32544

Device Problem Sticking (1597)

Patient Problem No Information (3190)

Event Date 07/07/2017

Event Type  Injury  

Manufacturer Narrative

This report relates to report 9680654-2017-00016.

Event Description

The pre-loaded wire was stuck in the pre-loaded catheter when attempting to remove.

Manufacturer Narrative

This report relates to report 9680654-2017-00016.

Event Description

The pre-loaded wire was stuck in the pre-loaded catheter when attempting to remove.Additional information: william cook (b)(4) initially reported this event based on available information at the time of complaint registration.New information was provided identifying that the product was actually a cook inc.Manufactured device.Report reference 1820334-2017-02718 was submitted by cook inc on the 22 august 17.

• Brand Name: UNKNOWN
• Type of Device: MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): COOK INC; 750 daniels way; eight mile plains; bloomington IN 47404
• Manufacturer Contact: nicolas bidaud ; 95 brandl street; eight mile plains; brisbane, qld 4113 ; AU 4113 ; 738411188
• MDR Report Key: 6727257
• MDR Text Key: 80497049
• Report Number: 9680654-2017-00017
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002325446
• UDI-Public: (01)10827002325446(17)200222(10)AC990274
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: G32544
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2017
• 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): Life Threatening; Required Intervention