FDA Adverse Event
Injury
Summary report: N
EKOSONIC KIT 106CM 12CM TZ
MDR report key: 10791309
·
Received November 5, 2020
Report
- Report Number
- 2134265-2020-15135
- Event Type
- Injury
- Date Received
- November 5, 2020
- Date of Event
- October 12, 2020
- Report Date
- November 4, 2020
- Manufacturer
- EKOS CORPORATION
- Product Code
- KRA
- UDI-DI
- 00858593006134
- PMA / PMN Number
- K182324
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CI
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED A SECOND PROCEDURE WAS NEEDED FOR CATHETER EXCHANGE. AFTER FOURTEEN HOURS OF TREATMENT, USING AN EKOSONIC KIT 106CM 12CM TZ FOR A BILATERAL PULMONARY THROMBOENDARTERECTOMY (PTE) CASE, A "NO ZONES/GROUPS ENABLED" ALARM OCCURRED. TROUBLESHOOTING EFFORTS WERE ATTEMPTED, BUT UNSUCCESSFUL. THE ALARM RETURNED WHEN EKOS WAS RESTARTED. THE PHYSICIAN DECIDED TO EXCHANGE THE CATHETER DUE TO THE CASE COMPLEXITY. TREATMENT WAS ABLE TO BE COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1262307 | EKOSONIC KIT 106CM 12CM TZ | CATHETER, CONTINUOUS FLUSH | KRA | EKOS CORPORATION | 500-55112 | 0191216014 | 00858593006134 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Required Intervention |