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 2018-12-20 for YASARGIL TI PERM STD-CLIP BAYO 12MM FT759T manufactured by Aesculap Inc.
[131384853]
(b)(4). When additional information is received a follow up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[131384855]
It was reported by the healthcare professional "when attaching the clip the surgeon realized the aneurysm clip was misaligned. " the surgeon removed the clip and tested by clipping a gauze to confirm the misalignment. The procedure was completed by using a new one. A delay in surgery has not been confirmed, when the time has been confirmed a follow up report will be submitted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2018-00603 |
| MDR Report Key | 8187129 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2018-12-20 |
| Date of Report | 2019-01-23 |
| Date of Event | 2018-11-28 |
| Date Facility Aware | 2019-01-15 |
| Date Mfgr Received | 2019-01-15 |
| Device Manufacturer Date | 2017-01-12 |
| Date Added to Maude | 2018-12-20 |
| 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 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3145515988 |
| Manufacturer G1 | AESCULAP INC |
| Manufacturer Street | 615 LAMBERT POINTE DRIVE |
| Manufacturer City | HAZELWOOD 63042 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 63042 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | YASARGIL TI PERM STD-CLIP BAYO 12MM |
| Generic Name | CEREBRO VASCULAR CLIPS |
| Product Code | HCH |
| Date Received | 2018-12-20 |
| Returned To Mfg | 2018-12-13 |
| Model Number | FT759T |
| Catalog Number | FT759T |
| Lot Number | 52292366 |
| 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 INC |
| Manufacturer Address | 615 LAMBERT POINTE DRIVE HAZELWOOD 63042 US 63042 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-12-20 |