FDA Adverse Event
Malfunction
Summary report: N
IAB : 8 FR - 40 CC
MDR report key: 2150550
·
Received June 22, 2011
Report
- Report Number
- 1219856-2011-00215
- Event Type
- Malfunction
- Date Received
- June 22, 2011
- Date of Event
- May 5, 2011
- Report Date
- June 22, 2011
- Manufacturer
- ARROW INTL., INC.
- Product Code
- DSP
- PMA / PMN Number
- K000729
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). F/U REPORT WILL BE FILED IF ADDITIONAL INFO BECOMES AVAILABLE.
Description of Event or Problem · 1
IT WAS REPORTED THAT WHILE IN THE CATH LAB, THE MD WAS INSERTING AN ULTRA 8 IAB-05840-U (INSERTION SITE FEMORAL ARTERY) ON THE .025 X 175 CM TEFLON 3MM "J" EXTRA STIFF SPRING WIRE GUIDE (SWG) IN THE CENTRAL LUMEN OF THE INTRA-AORTIC BALLOON (IAB) WHEN RESISTANCE WAS FELT AFTER 5 OR 6 CM AND COULD NOT ADVANCE BEYOND THAT. AS A RESULT, THE SWG WAS REMOVED. THERE WAS NO REPORT OF PT DEATH, COMPLICATIONS OR INJURY. THE PT OUTCOME IS FINE. ADDITIONAL INFO RECEIVED ON 06/15/2011 STATED THAT THE SHEATH WAS NOT REMOVED. THE SAME SHEATH AND SITE WERE USED. REFERENCE MDR #1219856-2011-000216 FOR THE SECOND EVENT INVOLVING THE SAME PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IAB : 8 FR - 40 CC | INTRA-AORTIC BALLOON PRODUCTS | DSP | ARROW INTL., INC. | KF0129003 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |