MAUDE Adverse Event Report: MEDTRONIC IRELAND ENDO ANCHOR SYSTEM HELI-FX TAA; ENDOVASCULAR SUTURING SYSTEM

Model Number	HG-18-90-22
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/29/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Failure to follow instructions (incorrect size device used).Other relevant device(s) are: catalog # hg-18-90-22, lot # 0008674157, use by date: 2019-06-12, manufactured date: 2017-06-12, (b)(4).
Event or Problem Description
A heli-fx guide catheter was inserted into a patient prophylactically during the implant of a valiant stent graft system in the thoracic aorta.It was reported that the physician opened the package for heli-fx guide catheter and noted that label on the box and sterile packaging was labelled as thoracic hg-18-90-22mm however the heli-fx device catheter label was 42mm.The physician elected to use the device even though the labelling was different.It was observed that the device would not deflect as much as the physician intended however physician did manage to place a few of the heli-fx aptus endoanchors.A second thoracic hg-18-90-22mm, also from the sales rep¿s trunk stock, with the same lot number was opened.However, the same labeling issue was on the device and the physician elected to not use this device.The hospital had a heli-fx aptus abdominal guide (sg-64) 22mm and the physician was able to use this device to complete deployment of the heli-fx aptus endoanchors.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
Additional information: both heli-fx devices were from medtronic owned trunk stock.Evaluation summary: the guide was removed from the packaging and inspected.The guide was labeled with a 42mm sticker on the handle and was deflected to confirm the device had a 42mm reach.The labeling material was peeled away by the sales rep which showed another layer behind it with labeling corresponding to a 42mm guide.It appears as the 22mm label was placed over the 42mm label.The cause of the event was most likely due to the label being swapped after sterilization, during over labelling in the reprocessing area at the manufacturing site (b)(4).Capa (b)(4) and a field corrective action # (b)(4) have been initiated.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDO ANCHOR SYSTEM HELI-FX TAA
• Common Device Name: ENDOVASCULAR SUTURING SYSTEM
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 6885698
• Report Number: 2953200-2017-01473
• Device Sequence Number: 760890
• Product Code: OTD
• UDI-Device Identifier: 00763000006655
• UDI-Public: 00763000006655
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K140036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/12/2019
• Device Model Number: HG-18-90-22
• Device Catalogue Number: HG-18-90-22
• Device Lot Number: 0008674157
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2017
• Initial Date Received by Manufacturer: 08/29/2017
• Supplement Date Received by Manufacturer: 09/11/2017
• Initial Report FDA Received Date: 09/22/2017
• Supplement Report FDA Received Date: 10/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: CVG-18-Q2-10
• Patient Sequence Number: 1
• Patient Age: 69 YR