FDA.reportPublic FDA data

MAUDE MDR 7814438

MDR report key
7814438
Report number
9610612-2018-00364
Event key
0
Event type
3
Date of event
2018-07-26
Date received
2018-08-24
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MS. NICOLE BROYLES
Address
615 LAMBERT POINTE DRIVE HAZELWOOD MO 63042 US
Phone
314-314-3145
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1YASARGIL TI PERM STD-CLIP BAYO 9MMPERMANENT ANEURYSM CLIPAESCULAP AGHCHFT758TFT758T52353639Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-08-2401. R

Event Narratives#

N

Patient 1

(B)(4). INVESTIGATION ON-GOING AT MANUFACTURING SITE. SUPPLEMENTAL REPORT WILL BE PROVIDED AT CONCLUSION OF INVESTIGATION AND/OR WHEN ADDITIONAL INFORMATION IS RECEIVED.

D

Patient 1

COUNTRY OF COMPLAINT: (B)(6). IT WAS REPORTED BY THE END USER THAT DURING SURGERY A YASARGIL ANEURYSM CLIP THAT WAS USED EXPERIENCED SCISSORING, WHICH WAS DETECTED DURING CHECKING THE CLIPPING CONDITION AFTER A BLOOD FLOW CHECK. THE CUSTOMER DID NOT DETECT ANY ISSUES WHEN INITIALLY PLACING THE CLIP. THE CLIP WAS REPLACED DURING THE OPERATION AND THE PROCEDURE WAS COMPLETED WITHOUT ANY PATIENT INJURY. NO ADDITIONAL INVENTION WAS REQUIRED.