MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2014-04-16 for YASARGIL TI PERM STD-CLIPSLT-CVD 6.5MM FT742T manufactured by Aesculap Ag & Co Kg.
[4367220]
Country of complaint: (b)(6). The surgeon clipped the operative site by ft714t and ft742t in tandem. The surgeon found a clip had slipped off when the angiography image was reviewed. Which clip (ft714t or ft742t) was slipped off is under investigation. ) state of brain aneurysm: dome diameter - 4mm; neck diameter - 2mm.
Patient Sequence No: 1, Text Type: D, B5
[11787379]
Us reporting agent notified on (b)(4) 2014. Mfg site eval: clips received show traces of wear which may be a sign of multiple use, or improper use of application forceps. There are no indications of mfg or material defects. The cause of the failure can not be determined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2916714-2014-00245 |
| MDR Report Key | 3805229 |
| Report Source | 01,07 |
| Date Received | 2014-04-16 |
| Date of Report | 2014-04-16 |
| Date of Event | 2014-03-07 |
| Date Mfgr Received | 2014-03-17 |
| Device Manufacturer Date | 2013-10-01 |
| Date Added to Maude | 2014-05-29 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MICHELLE LINK |
| Manufacturer Street | 615 LAMBERT POINTE DR |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3145515938 |
| Manufacturer G1 | AESCULAP AG & CO KG |
| 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 STD-CLIPSLT-CVD 6.5MM |
| Generic Name | CEREBRO VASCULAR CLIPS |
| Product Code | HCH |
| Date Received | 2014-04-16 |
| Model Number | FT742T |
| Catalog Number | FT742T |
| Lot Number | 51894500 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AESCULAP AG & CO KG |
| Manufacturer Address | TUTTLINGEN DE 78532 US 78532 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-04-16 |