MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 02 report with the FDA on 2003-10-01 for CORLINK AAD PROXIMAL 100 manufactured by Bypass Maakafim Ltd..
[365849]
The pt is participating in a marketing study. According to the info rec'd from the surgeon, the bypass performed using corlink proximal device was found to be occluded (82% stenosis) at angiography test performed 3-month post surgery. Intraoperative report showed mild bleeding post device deployment that was self terminated in one minute. The pt does not experience any clinical symptoms at this time, no intervention is required.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 3003217124-2003-00005 |
MDR Report Key | 521797 |
Report Source | 02 |
Date Received | 2003-10-01 |
Date of Report | 2003-09-25 |
Date of Event | 2003-08-06 |
Date Mfgr Received | 2003-08-11 |
Device Manufacturer Date | 2002-01-01 |
Date Added to Maude | 2004-04-26 |
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 | 0 |
Manufacturer Contact | MS. LIAT DIAMANT, MGR |
Manufacturer Street | 2 HASADNAOT STREET |
Manufacturer City | HERZELIYA 46728 |
Manufacturer Country | IS |
Manufacturer Postal | 46728 |
Manufacturer Phone | 99704324 |
Manufacturer G1 | * |
Manufacturer Street | * |
Manufacturer City | * |
Manufacturer Country | * |
Single Use | 3 |
Remedial Action | PM |
Previous Use Code | 3 |
Removal Correction Number | NA |
Event Type | 3 |
Type of Report | 3 |
Brand Name | CORLINK AAD PROXIMAL |
Generic Name | ANASTOMOTIC DEVICE |
Product Code | LNN |
Date Received | 2003-10-01 |
Model Number | PROXIMAL |
Catalog Number | 100 |
Lot Number | SP 205, INP 750 |
ID Number | * |
Device Expiration Date | 2004-12-01 |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Eval'ed by Mfgr | R |
Implant Flag | Y |
Date Removed | * |
Device Sequence No | 1 |
Device Event Key | 510924 |
Manufacturer | BYPASS MAAKAFIM LTD. |
Manufacturer Address | 3 HASADNAOT STREET HERZELIA IS 46728 |
Baseline Brand Name | CORLINK AAD PROXIMAL |
Baseline Generic Name | ANASTOMOTIC DEVICE |
Baseline Model No | PROXIMAL |
Baseline Catalog No | 153 |
Baseline ID | * |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Other | 2003-10-01 |