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 2018-09-05 for YASARGIL TI PERM STD-CLIP BAYO 12MM FT759T manufactured by Aesculap Ag.
[119321713]
(b)(4). Manufacturing site evaluation: the implant arrived in an unknown used condition and available for investigation. The implant was thermal decontaminated. The components have been examined visually and microscopically with the digital microscope and digital camera. A visual inspection of the clip was performed. A selective closed jaw was found. Also a deformed clip, the jaw was not aligned. There was visible damage and traces of usage. The device quality and manufacturing history records have been checked for the lot number and fund to be according to the specification, valid at the time of production. No similar incidents have been filed with products from this batch. The root cause of the problem is most probably usage related.
Patient Sequence No: 1, Text Type: N, H10
[119321714]
It was reported by the healthcare professional to the company sales representative "jaw opened post operatively in patient. Patient had to wheel back to ot because rupture was not sealed. And another clip had to be inserted while the defected one was removed. "initial clipping was done during an intraoperatively rupture, where the clip was placed rather inadvertently and not on the aneurysm. During the re-surgery (second operation), which was approximately 1 month later, the clip was retrieved and found to be in that condition, despite not being on any vessel. " on (b)(6) 2017: clipping was done on (b)(6) 2017 in which the faulty clip was used. Date of event (b)(6) 2017 a cta was done just days before the 2nd re-ruptured which noted that the clips had displaced. However, patient re-ruptured. Before a 2nd operation could be planned. All med watch submissions related to this report are: 9610612-2018-00384 (this report), 9610612-2018-00394, 9610612-2018-00395, 9610612-2018-00404.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2018-00384 |
| MDR Report Key | 7847482 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2018-09-05 |
| Date of Report | 2018-10-30 |
| Date of Event | 2017-06-28 |
| Date Facility Aware | 2018-08-07 |
| Date Mfgr Received | 2018-08-17 |
| Device Manufacturer Date | 2017-01-12 |
| Date Added to Maude | 2018-09-05 |
| 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 | 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-CLIP BAYO 12MM |
| Generic Name | CRANIAL IMPLANTS |
| Product Code | HCH |
| Date Received | 2018-09-05 |
| Returned To Mfg | 2018-08-13 |
| Model Number | FT759T |
| Catalog Number | FT759T |
| Lot Number | 52292366 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 19 MO |
| 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. Hospitalization; 2. Required No Informationntervention | 2018-09-05 |