FDA Adverse Event
Injury
Summary report: N
SGW ATW .014 195CM, FLOPPY STR
MDR report key: 765513
·
Received September 22, 2006
Report
- Report Number
- 1016427-2006-00095
- Event Type
- Injury
- Date Received
- September 22, 2006
- Date of Event
- August 13, 2006
- Report Date
- September 21, 2006
- Manufacturer
- CORDIS CORPORATION
- Product Code
- DQX
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- EG
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION WILL BE SUBMITTED UPON 30 DAYS OF RECEIPT.
Description of Event or Problem · 1
WHILE RETRACTING THE SGW ATW WIRE FROM THE PATIENT'S BODY, THE WIRE WAS "CUT IN ITS SHAFT, WHILE THE REST OF THE WIRE WAS PULLED OUT OF THE GUIDING CATHETER." PART OF THE WIRE WAS LEFT WITHIN THE PATIENT. THE MOST PROXIMAL PART STARTED AT THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) AND THE MOST DISTAL PART WAS AT THE SIGHT OF THE TOTAL OCCLUSION. SURGICAL CONSULTATION WAS IMMEDIATELY SOUGHT AND THE PATIENT WAS TRANSFERRED TO CCU FOR FURTHER MANAGEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SGW ATW .014 195CM, FLOPPY STR | CARDIOLOGY WIRES & METALS | DQX | CORDIS CORPORATION | NA | F1105816 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention |