FDA Adverse Event
Malfunction
Summary report: N
NA
MDR report key: 1881110
·
Received October 1, 2010
Report
- Report Number
- 1219856-2010-00677
- Event Type
- Malfunction
- Date Received
- October 1, 2010
- Date of Event
- September 15, 2010
- Report Date
- September 24, 2010
- Manufacturer
- ARROW INTL., INC.
- Product Code
- DSP
- PMA / PMN Number
- UNK
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). SAMPLE WILL NOT BE RETURNED EVAL.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE "OPERATOR" FOUND THAT THE INTRA-AORTIC BALLOON (IAB) STUCK IN THE SUPER ARROW-FLEX (SAF) SHEATH DURING THE INSERTION PHASE. THE SAF SHEATH WAS INSERTED INTO THE PT'S FEMORAL ARTERY. THE OPERATOR WAS NOT ONLY UNABLE TO INSERT THE IAB THROUGH THE SAF SHEATH, BUT THE OPERATOR ALSO OBSERVED A BULGING AT THE PROXIMAL PART OF THE MEMBRANE. IT IS UNK IF THIS WAS DUE TO EXCESSIVE MANIPULATION OF THE IAB CATHETER. IT IS UNK IF THERE WAS A PT DEATH OR INJURY, OR IF MEDICAL/SURGICAL INTERVENTION WAS REQUIRED. THERE IS NO INFO AVAILABLE ABOUT THE THERAPY BEING DELAYED OR INTERRUPTED. THE PT OUTCOME IS LISTED AS "UNK."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NA | INTRA-AORTIC BALLOON PRODUCTS | DSP | ARROW INTL., INC. | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |