FDA Adverse Event
Injury
Summary report: N
ARROW INTERNATIONAL INC
MDR report key: 1852870
·
Received September 29, 2010
Report
- Report Number
- MW5017624
- Event Type
- Injury
- Date Received
- September 29, 2010
- Date of Event
- September 29, 2010
- Report Date
- September 29, 2010
- Manufacturer
- ARROW INTL INC
- Product Code
- DSP
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- VA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THREE ARROW IABPS WERE UNABLE TO BE PASSED THRU THE SHEATH SUPPLIED WITH THE KIT. THE PT PRESENTED WITH A STEMI AND THE IABP WAS BEING INSERTED FOR CARDIOGENIC SHOCK DURING A PCI PROCEDURE. A FOURTH IABP WAS ABLE TO BE INSERTED BUT THERE WAS A DELAY IN THERAPY AND PT REMAINS CRITICALLY ILL IN A CCU NOW.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ARROW INTERNATIONAL INC | IABP | DSP | ARROW INTL INC | IAB-05840-U | MF0063353 | |
| 2 | ARROW INTERNATIONAL INC | IABP | DSP | ARROW INTERNATIONAL INC | IAB-05840-U | MS9110269 | |
| 3 | ARROW INTERNATIONAL INC | IABP | DSP | ARROW INTERNATIONAL INC | IAB-05840-U |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR | Life Threatening |