|
|
| Model Number SYSTEM 98 |
|
Patient Outcome
Other;
|
|
Event Description
|
Balloon inserted during cardiac catheterization procedure at approx.
12:15 pm.
At approx.
14:30 blood was noted in the iab helium tube.
Balloon was removed.
Tear was noted after removal.
|
| |
|
Search Alerts/Recalls
|
|
|
| Brand Name | DATASCOPE |
|---|
| Type of Device | INTRA-AORTIC BALLOON |
|---|
| Baseline Brand Name | SYSTEM 98 |
|---|
| Baseline Generic Name | IABP |
|---|
| Baseline Catalogue Number | 0998-00-0446-XX |
|---|
| Baseline Model Number | SYSTEM 98 |
|---|
| Baseline Device Family | INTRA-AORTIC BALLOON PUMP |
|---|
| Baseline Device 510(K) Number | K965236 |
|---|
| Baseline Device PMA Number | |
|---|
| Baseline Preamendment? |
No
|
|---|
| Transitional? |
No
|
|---|
| 510(K) Exempt? |
No
|
|---|
| Shelf Life(Months) | NA |
|---|
| Date First Marketed | 12/13/1982 |
|---|
| Manufacturer (Section D) |
| DATASCOPE |
| 800 macarthur blvd. |
| mahwah NJ 07430 |
|
| Device Event Key | 440315 |
|---|
| MDR Report Key | 451316 |
|---|
| Event Key | 427412 |
|---|
| Report Number | MW1028000 |
|---|
| Device Sequence Number | 1 |
|---|
| Product Code | DSP |
|---|
| Report Source |
Voluntary
|
|---|
| Report Date |
03/28/2003 |
| 1 Device Was Involved in the Event | |
| 1 Patient Was Involved in the Event | |
| Date FDA Received | 03/28/2003 |
|---|
| Is This An Adverse Event Report? |
No
|
|---|
| Is This A Product Problem Report? |
Yes
|
|---|
| Device Operator |
Health Professional
|
| Device MODEL Number | SYSTEM 98 |
|---|
| Device Catalogue Number | DL9.5 |
|---|
| Device LOT Number | 12890932 |
|---|
| Was Device Available For Evaluation? |
Yes
|
|---|
| Is the Device an Implant? |
No
|
|---|
| Is this an Explanted Device? |
No Answer Provided
|
|---|
|
|
Database last updated on January 30, 2009
CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaimer
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page
Center for Devices and Radiological Health / CDRH
