FDA Adverse Event
Injury
Summary report: N
CVC SET: 2-LUMEN 12 FR X 20 CM
MDR report key: 840472
·
Received April 16, 2007
Report
- Report Number
- 1036844-2007-00038
- Event Type
- Injury
- Date Received
- April 16, 2007
- Date of Event
- March 20, 2007
- Report Date
- April 16, 2007
- Manufacturer
- ARROW INTL., INC.
- Product Code
- DQO
- PMA / PMN Number
- K900263
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- INVALID DATA
Narratives
Additional Manufacturer Narrative · 1
A F/U REPORT WILL BE FILED IF MORE INFO BECOMES AVAILABLE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DILATOR WAS PASSED OVER THE GUIDEWIRE AND THEN REMOVED. THE 20CM CATHETER WAS PASSED OVER GUIDEWIRE & PT COMPLAINED OF PAIN. CATHETER WAS REMOVED, BUT GUIDEWIRE COULDN'T BE REMOVED & THERE WAS RESISTANCE WHEN WITHDRAWAL WAS ATTEMPTED. AT THIS POINT, GUIDEWIRE STARTED TO FRAY (LOCATION ON THE WIRE THAT FRAYED WAS UNDETERMINED). THEREFORE, USERS ABANDONED ATTEMPT TO REMOVE GUIDEWIRE AT THIS POINT. GUIDEWIRE WAS SURGICALLY REMOVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CVC SET: 2-LUMEN 12 FR X 20 CM | ARROWG+ARD CATHETER PRODUCTS | DQO | ARROW INTL., INC. | NA | HF6072562 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | Required Intervention |