FDA Adverse Event
Malfunction
Summary report: N
MIKRO-CATH
MDR report key: 11632115
·
Received April 7, 2021
Report
- Report Number
- 1625382-2017-00001
- Event Type
- Malfunction
- Date Received
- April 7, 2021
- Date of Event
- May 26, 2017
- Report Date
- June 28, 2017
- Manufacturer
- MILLAR INC.
- Product Code
- DXO
- PMA / PMN Number
- K093111
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE SURGICAL TEAM'S PHYSICIAN ASSISTANTS ATTEMPTED TO REMOVE THE MIKRO-CATH FROM THE PATIENT BY PULLING THE CATHETER FROM THE CHEST WALL AT BEDSIDE. THEY PHYSICIAN ASSISTANT FELT RESISTANCE WHILE ATTEMPTING TO PULL THE CATHETERS OUT AND ENDED THE PROCEDURE. THE DOCTOR MET WITH THE PATIENT AND DECIDED TO CUT THE CATHETER LEAD AT THE SKIN SITE. IT IS UNSURE HOW MUCH CATHETER HAS BEEN LEFT IN THE PATIENT. THE PHYSICIAN BELIEVES THE CATHETER TIP AND REMAINING LENGTH IS LOCATED IN THE CHEST OUTSIDE THE HEART.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 529062 | MIKRO-CATH | PRESSURE TRANSDUCER CATHETER, PRODUCT CODE DXO | DXO | MILLAR INC. | 825-0101 | 38554 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Other |