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

Model Number	G32544
Health Effect - Clinical Code	No Information (3190)
Date of Event	07/07/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report relates to report 9680654-2017-00016.
Event or Problem Description
The pre-loaded wire was stuck in the pre-loaded catheter when attempting to remove.
Additional Manufacturer Narrative
This report relates to report 9680654-2017-00016.
Event or Problem 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
• Common Device Name: MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): COOK INC; 750 daniels way; eight mile plains; bloomington IN 47404
• MDR Report Key: 6727257
• Report Number: 9680654-2017-00017
• Device Sequence Number: 13666918
• Product Code: MIH
• UDI-Device Identifier: 10827002325446
• UDI-Public: (01)10827002325446(17)200222(10)AC990274
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P020018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2017

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?: No
• Operator of Device: Health Professional
• Device Model Number: G32544
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/12/2017
• Supplement Date Received by Manufacturer: 07/12/2017
• Initial Report FDA Received Date: 07/19/2017
• Supplement Report FDA Received Date: 08/28/2017
• 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: Life Threatening; Required Intervention