MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-07-03 for YASARGIL TI PERM MINI-CLIPLGT-CVD5.2MM FT726T manufactured by Aesculap Ag.
[113338004]
(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.
Patient Sequence No: 1, Text Type: N, H10
[113338005]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2018-00270 |
| MDR Report Key | 7660856 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-07-03 |
| Date of Report | 2018-07-03 |
| Date of Event | 2018-06-04 |
| Date Facility Aware | 2018-06-12 |
| Date Mfgr Received | 2018-06-05 |
| Device Manufacturer Date | 2016-10-18 |
| Date Added to Maude | 2018-07-03 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. NICOLE BROYLES |
| Manufacturer Street | 615 LAMBERT POINTE DRIVE |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer G1 | AESCULAP AG |
| Manufacturer Street | PO BOX 40 |
| Manufacturer City | TUTTLINGEN, 78501 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78501 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | YASARGIL TI PERM MINI-CLIPLGT-CVD5.2MM |
| Generic Name | YASARGIL TITANIUM ANEURYSM CLIPS PE |
| Product Code | HCH |
| Date Received | 2018-07-03 |
| Returned To Mfg | 2018-06-21 |
| Model Number | FT726T |
| Catalog Number | FT726T |
| Lot Number | 52263473 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AESCULAP AG |
| Manufacturer Address | PO BOX 40 TUTTLINGEN, 78501 GM 78501 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-07-03 |