SENSATION PLUS 8FR. 50CC IAB & ACCESSORIES (W/PRESSURE TUBES, NO STYLET)
Report
- Report Number
- 2248146-2024-00190
- Event Type
- Malfunction
- Date Received
- April 1, 2024
- Date of Event
- March 11, 2024
- Report Date
- November 22, 2024
- Manufacturer
- DATASCOPE CORP.
- Product Code
- DSP
- UDI-DI
- 10607567108605
- PMA / PMN Number
- K133074
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
INITIAL REPORTER: (B)(6). THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER SO WE ARE UNABLE TO COMPLETE AN EVALUATION. IF PROVIDED WE WILL SEND A SUPPLEMENTAL REPORT WITH OUR ADDITIONAL FINDINGS. REFERENCE COMPLAINT #1002007 H3 OTHER TEXT : DEVICE NOT RETURNED.
PROVIDING UPDATED DEVICE IDENTIFICATION INFORMATION IN ALIGNMENT WITH GUDID. UDI # IS INCOMPLETE AS THE LOT #, MANUFACTURE DATE, EXP. DATE WERE NOT PROVIDED. THIS INFORMATION WAS REQUESTED FROM THE CUSTOMER; HOWEVER, DESPITE OUR BEST EFFORTS, NO INFORMATION HAS BEEN RECEIVED. IF ANY PERTINENT INFORMATION IS RECEIVED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. COMPLAINT RECORD ID # (B)(4).
THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER SO WE ARE UNABLE TO COMPLETE AN EVALUATION. REFERENCE COMPLAINT #(B)(4).
IT WAS REPORTED THAT PRIOR TO INTRA-AORTIC BALLOON (IAB) THERAPY, THE IAB WAS FOUND TO BE MISSING THE ONE-WAY VALVE. THE IAB WAS REPLACED AND THERAPY WAS PROVIDED. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.
N/A.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1665553 | SENSATION PLUS 8FR. 50CC IAB & ACCESSORIES (W/PRESSURE TUBES, NO STYLET) | SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL | DSP | DATASCOPE CORP. | 0684-00-0576-01 | UNKNOWN | 10607567108605 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Male |