MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2018-08-23 for YASARGIL TI PERM MINI-CLIP STR 5MM FT710T manufactured by Aesculap Ag.
[118085927]
(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.
Patient Sequence No: 1, Text Type: N, H10
[118085928]
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).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2018-00386 |
| MDR Report Key | 7811197 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2018-08-23 |
| Date of Report | 2018-09-25 |
| Date of Event | 2018-07-23 |
| Date Facility Aware | 2018-08-08 |
| Date Mfgr Received | 2018-09-10 |
| Date Added to Maude | 2018-08-23 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 Phone | 3145515988 |
| Manufacturer G1 | CHRISTOPH MIETHKE GMBH & CO. KG |
| Manufacturer Street | 2 ULANENWEG |
| Manufacturer City | POTSDAM D, 14469 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 14469 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | YASARGIL TI PERM MINI-CLIP STR 5MM |
| Generic Name | CRANIAL IMPLANTS |
| Product Code | HCH |
| Date Received | 2018-08-23 |
| Model Number | FT710T |
| Catalog Number | FT710T |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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. Required No Informationntervention | 2018-08-23 |