MAUDE Adverse Event Report: AESCULAP AG YASARGIL TI PERM MINI-CLIP STR 5MM; CRANIAL IMPLANTS

Model Number FT710T

Device Problem Difficult to Open or Close (2921)

Patient Problem Aneurysm (1708)

Event Date 07/23/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: evaluation on-going event related to the use of the medical device associated with direct damage to the patient.Date of explant: unknown.Pending further information.

Event Description

It was reported by the healthcare professional to the company sales representative "an aneurysm surgery is performed.Intervention by the surgeon, who reports that he used a clip for intracranial aneurysm: 5 mm permanent mini clip, indicating that when "i place the clips on the neck of the aneurysm it does not occlude, it is opened," it is left permeable to the aneurysm and this may be cause of sub arachnoid hemorrhage, then closes with a clip (does not refer to the measure or characteristics of it).

Manufacturer Narrative

No product is at hand.A review of the device quality and manufacturing history records is not possible because the batch number is unknown.No product available and therefore it is hardly possible to determine an exact conclusion.Due to the circumstances that it is not possible to determine a definitive root cause for this failure, the risk analysis is not applicable.According to the quality standard, a material defect and production error can be excluded.Since these clips are subject to a 100% inspection of the surface, geometry and closing force, a delivery condition with poor geometry is excluded.Unfortunately due to a lack of data and without the product, we can not determine the exact cause.No capa is necessary.

• Brand Name: YASARGIL TI PERM MINI-CLIP STR 5MM
• Type of Device: CRANIAL IMPLANTS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 7811197
• MDR Text Key: 118085927
• Report Number: 9610612-2018-00386
• Device Sequence Number: 1
• Product Code: HCH
• Combination Product (y/n): N
• PMA/PMN Number: K970050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 09/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FT710T
• Device Catalogue Number: FT710T
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 08/08/2018
• Date Manufacturer Received: 09/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention