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 2016-05-12 for YASARGIL TI PERM STD-CLIPSLT-CVD 6.5MM FT742T manufactured by Aesculap Ag.
[45030224]
(b)(4). (b)(4). Manufacturing site evaluation: evaluation on-going.
Patient Sequence No: 1, Text Type: N, H10
[45030285]
Country of complaint: (b)(6). According to the customer the blood vessels, brownish skin grew around the aneurism clip.
Patient Sequence No: 1, Text Type: D, B5
[53955728]
The received clip was analyzed using a digital microscope. The clip shows indications of use, including several deep scratches. This indicates multiple applications which is explicitly forbidden, noted in ifu. There are pressure marks on the branch and a deformed spring. The most likely cause is use of an incorrect application-forceps. This would also explain gap between the jaw parts. The grown tissue is a excessive tissue reaction. This is not exceptional and possible in principle. This is the first known complaint, concerning this symptom. The device quality and manufacturing history records have been checked for the serial number. The device history file has been checked and find to be according to the specification valid at the time of production. No similar incidents have been filed with products from this batch. Based on the information available as well as a result of our investigation the root cause of the failure is most probably user related. Corrective action is not required. Additional information: post operative medical intervention required. Pt identifier, age/date of birth, sex, and weight info were not provided on original report. Service number in model/lot # has been added, as well as implant date and explants date. Initially reported as product problem; other serious this should now be considered adverse event/required intervention original date of implant reported as 2011. Month/day were not possible.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2916714-2016-00365 |
| MDR Report Key | 5650317 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-05-12 |
| Date of Report | 2016-08-01 |
| Date of Event | 2016-03-30 |
| Date Facility Aware | 2016-05-04 |
| Date Mfgr Received | 2016-06-17 |
| Device Manufacturer Date | 2009-09-11 |
| Date Added to Maude | 2016-05-12 |
| 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 Phone | 3145515988 |
| 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 STD-CLIPSLT-CVD 6.5MM |
| Generic Name | CRANIAL IMPLANTS |
| Product Code | HCH |
| Date Received | 2016-05-12 |
| Model Number | FT742T |
| Catalog Number | FT742T |
| Lot Number | 51587391 |
| 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. Other; 2. Required No Informationntervention | 2016-05-12 |