FDA Adverse Event
Malfunction
Summary report: N
GUGLIELMI DETACHABLE COIL (GDC)
MDR report key: 1523735
·
Received November 2, 2009
Report
- Report Number
- 2939204-2009-00816
- Event Type
- Malfunction
- Date Received
- November 2, 2009
- Date of Event
- September 10, 2009
- Report Date
- October 7, 2009
- Manufacturer
- NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORP.
- Product Code
- HCG
- PMA / PMN Number
- K031049
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION WAS RECEIVED FROM THE USER FACITLITY STATING THAT APPROXIMATELY 1MM OF THE LAST COIL PROTRUDED FROM THE ANEURYSM POST DETACHMENT.
Additional Manufacturer Narrative · 1
(B)(4) COIL PROTRUSION. K042539.
Description of Event or Problem · 1
DURING THE COIL EMBOLIZATION OF THE ANTERIOR COMMUNICATING ARTERY ANEURYSM, A COIL PROLAPSED. NO FURTHER INFORMATION WAS PROVIDED. THERE WAS NO REPORTED CLINICAL CONSEQUENCE TO THE PATIENT.
Description of Event or Problem · 1
DURING THE COIL EMBOLIZATION OF THE ANTERIOR COMMUNICATING ARTERY ANEURYSM, A COIL PROLAPSED. NO FURTHER INFORMATION WAS PROVIDED. THERE WAS NO REPORTED CLINICAL CONSEQUENCE TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GUGLIELMI DETACHABLE COIL (GDC) | DEVICE, NEUROVASCULAR EMBOLIZATION | HCG | NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORP. | M0033432020 | 11825297 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 26 YR | 10,000U OF HEPARIN| SEVEN GDC COILS (BOSTON SCIENTIFIC) |