MAUDE Adverse Event Report: AESCULAP AG YASARGIL TI PERM MINI-CLIPLGT-CVD5.2MM; YASARGIL TITANIUM ANEURYSM CLIPS PE

Model Number FT726T

Device Problems Mechanical Problem (1384); Difficult to Open or Close (2921)

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

Event Date 06/04/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: five aneurysm clips were returned for investigation.The clips were scratched and deformed.Especially the geometry of the jaws are no longer even.The investigation was carried out visually using a digital microscope.At all provided products several deviations on the surface, the geometry and the symmetry can be found.These deviations were most likely caused by improper handling during application most likely repeatedly open and close clip.The device quality and manufacturing history records have been checked for all available lot numbers.The device history fie has been checked and found to be according to the specification valid at the time of production.No similar incidents have been filed with products from these batches.Based on the information available as well as a result of investigation the root cause of the failure is most probably related to an insufficient usage.A capa is not necessary.

Event Description

Country of complaint: (b)(6).It was reported that when using the clip, the clip does not close completely.When placing the semi-circular clip on the neck of the aneurysm, this opened the middle cerebral artery that was with a temporary clip, the 5mm semi-curved clips opened, leaving the aneurysm permeable.When placing the clip on the basis of the aneurysm, there is no proper closing and it is easily detached from its position so it does not meet the desired objective (it does not work).All medwatch submissions related to this report are: 9610612-2018-00266; 9610612-2018-00267; 9610612-2018-00268; 9610612-2018-00269.

• Brand Name: YASARGIL TI PERM MINI-CLIPLGT-CVD5.2MM
• Type of Device: YASARGIL TITANIUM ANEURYSM CLIPS PE
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042
• MDR Report Key: 7660856
• MDR Text Key: 113338004
• Report Number: 9610612-2018-00270
• Device Sequence Number: 1
• Product Code: HCH
• Combination Product (y/n): N
• Reporter Country Code: PE
• PMA/PMN Number: K970050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FT726T
• Device Catalogue Number: FT726T
• Device Lot Number: 52263473
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2018
• Distributor Facility Aware Date: 06/12/2018
• Device Age: 1 YR
• Date Manufacturer Received: 06/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/18/2016
• 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
• Patient Outcome(s): Other