MAUDE Adverse Event Report: MEDTRONIC-SUNNYVALE/APTUS ENDOSYSTEMS ENDO ANCHOR SYSTEM - HELI-FX AAA; ENDOVASCULAR SUTURING SYSTEM

Model Number HG-16-62-28

Device Problem Inability to Irrigate (1337)

Patient Problem No Patient Involvement (2645)

Event Date 08/06/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that an aptus heli-fx guide was selected for use.It was reported that when attempting to flush the dilator of the guide, it would not flush.The guide was not used in the patient.The physician successfully completed the case using another guide.No clinical sequelae were reported and the patient is fine.

Manufacturer Narrative

Device evaluation has been completed.The reported complaint was unable to be confirmed as the obturator was able to be flushed without issue.No defects or obstructions were noted which would have prevented proper flushing of the obturator.

• Brand Name: ENDO ANCHOR SYSTEM - HELI-FX AAA
• Type of Device: ENDOVASCULAR SUTURING SYSTEM
• Manufacturer (Section D): MEDTRONIC-SUNNYVALE/APTUS ENDOSYSTEMS; 271 gibraltar dr; sunnyvale CA 74089
• Manufacturer (Section G): MEDTRONIC CARDIOVASCULAR; 3576 unocal place; santa rosa CA 95403
• Manufacturer Contact: eric elliott ; 3576 unocal place; santa rosa, CA 95403 ; 7075912586
• MDR Report Key: 5032720
• MDR Text Key: 25038537
• Report Number: 2953200-2015-01452
• Device Sequence Number: 1
• Product Code: OTD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Report Date: 09/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2016
• Device Model Number: HG-16-62-28
• Device Catalogue Number: HG-16-62-28
• Device Lot Number: 49234-029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/02/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2014
• 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