TRANSRAY PLUS 7.5FR. 35CC IAB
Report
- Report Number
- 2248146-2024-00316
- Event Type
- Malfunction
- Date Received
- May 20, 2024
- Date of Event
- April 30, 2024
- Report Date
- February 28, 2025
- Manufacturer
- DATASCOPE CORP.
- Product Code
- DSP
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE PRODUCT WAS RETURNED WITH THE MEMBRANE COMPLETELY UNFOLDED AND BLOOD FOUND ON THE EXTERIOR OF THE CATHETER, BETWEEN SHEATH AND CATHETER AND WITHIN THE INNER LUMEN. THE NON-MAQUET SHEATH WAS RETURNED PARTIALLY COVERING THE MEMBRANE TWO KINKS WERE OBSERVED ON THE CATHETER APPROXIMATELY 73.9CM AND 48.5CM FROM THE IAB TIP. THE PRESSURE TUBING AND THE THREE-WAY STOPCOCK WERE RETURNED. - A SENSOR OUTPUT TEST WAS PERFORMED, AND THE SENSOR WAS FOUND NOT TO BE WITHIN SPECIFICATION THE ROOT CAUSE OF THE REPORTED FAILURE "IAB-DIFFICULT/UNABLE TO MONITOR PRESSURE (SENSOR PRESSURE)" IS CENTERED ON THE SENSOR/SENSOR CABLE. THE CATHETER KINKS/PINCHES DID NOT AFFECT THE FUNCTIONALITY OF IAB PUMPING AND VOLUME BUT MAY HAVE IMPACTED THE SENSOR CABLE FUNCTIONALITY. DUE TO THE NUMEROUS POINTS OF INSPECTION AND VERIFICATION, THE SENSOR CABLE FUNCTIONALITY LOSS DID NOT OCCUR PRIOR TO SHIPMENT TO THE CUSTOMER AS THE IAB WAS DEEMED ACCEPTABLE PRIOR TO LEAVING THE MANUFACTURING FACILITY. THE ROOT CAUSE OF DAMAGE TO THE DEVICE'S SENSOR AND CATHETER KINKS/PINCHES CANNOT BE DETERMINE, AS IT OCCURRED AFTER SHIPMENT OF THE DEVICE AND WAS OUT OF GETINGE'S CONTROL. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT. NO NONCONFORMANCES WERE FOUND THAT ARE CONSIDERED TO BE RELATED TO THE EVENT. REFERENCE COMPLAINT #(B)(4).
EVENT SITE POSTAL CODE - (B)(6). EVENT SITE NAME - (B)(6) MEDICAL CENTER. 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. COMPLAINT RECORD ID # 1033016 H3 OTHER TEXT : DEVICE NOT RETURNED.
NO UDI IS PROVIDED AS PRODUCT WAS DISCONTINUED PRIOR TO GUDID IMPLEMENTATION TIMELINE.
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 DURING INTRA-AORTIC BALLOON (IAB) THERAPY, THE SENSOR PRESSURE WENT FLAT DURING USE. AFTER A WHILE, THE SENSOR PRESSURE WENT BACK TO NORMAL AND THERAPY CONTINUED. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.
N/A.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1617600 | TRANSRAY PLUS 7.5FR. 35CC IAB | SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL | DSP | DATASCOPE CORP. | 3000327916 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |