MAUDE Adverse Event Report: WILLIAM A. COOK AUSTRALIA, PTY LTD ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT PROXIMAL BODY; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Catalog Number ZFEN-P-2-36-137-R

Device Problems Flaked (1246); Device Packaging Compromised (2916)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/18/2016

Event Type  malfunction  

Event Description

The physician opened the package and noticed that the hydrophilic coating on the sheath was flaking off.He wiped down the coating with saline and tried remove all the flakiness from the device.

Manufacturer Narrative

The product was not returned therefore no physical evaluation of the device could be completed however a photo of the complaint device was supplied confirming the complaint.The work order record for ac980695 was reviewed and appeared complete and correct.One-hundred percent (100%) of sheath assemblies are qc inspected at incoming qc for any surface non-conformities, including flaking and peeling, based on the information present, a definitive root cause for the complaint could not be determined.Appropriate personnel will continue to monitor for similar events.The product was not returned therefore no physical evaluation of the device could be completed however a photo of the complaint device was supplied confirming the complaint.The work order record for ac980695 was reviewed and appeared complete and correct.One-hundred percent (100%) of sheath assemblies are qc inspected at incoming qc for any surface non-conformities, including flaking and peeling, based on the information present, a definitive root cause for the complaint could not be determined.Appropriate personnel will continue to monitor for similar events.

Event Description

The physician opened the package and noticed that the hydrophilic coating on the sheath was flaking off.He wiped down the coating with saline and tried remove all the flakiness from the device.

• Brand Name: ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT PROXIMAL BODY
• Type of Device: MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): WILLIAM A. COOK AUSTRALIA, PTY LTD; 95 brandl street; eight mile plains; brisbane QLD 4 113; AS QLD 4113
• Manufacturer Contact: nicolas bidaud ; 95 brandl street; eight mile plains; brisbane, qld 4113 ; AU 4113 ; 738411188
• MDR Report Key: 6084552
• MDR Text Key: 59843924
• Report Number: 9680654-2016-00015
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002325507
• UDI-Public: (01)10827002325507(17)190826(10)AC980695
• 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: 12/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ZFEN-P-2-36-137-R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/18/2016
• Date Device Manufactured: 08/26/2016
• 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