TRANSRAY PLUS 7.5FR. 40CC IAB
Report
- Report Number
- 2248146-2024-00317
- Event Type
- Death
- Date Received
- May 20, 2024
- Date of Event
- April 20, 2024
- Report Date
- February 28, 2025
- Manufacturer
- DATASCOPE CORP.
- Product Code
- DSP
- PMA / PMN Number
- KO63525
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
ADDITIONAL MFG NARRATIVE/CORR. DATA TO CHANGE THE LOCATION FROM WHICH THE OPTICAL FIBER BREAK WAS LOCATED. THE PRODUCT WAS RETURNED WITH THE MEMBRANE COMPLETELY UNFOLDED AND BLOOD ON THE INTERIOR AND EXTERIOR OF THE CATHETER AND BETWEEN THE CATHETER AND THE SHEATH. THE RETURNED SHEATH WAS NOT A MAQUET PRODUCT. THE OPTICAL FIBER WAS FOUND TO BE BROKEN WITHIN THE MEMBRANE APPROXIMATELY 1.8CM FROM REAR SEAL. THE INNER LUMEN WAS FOUND OCCLUDED WITH DRIED BLOOD. THE OCCLUSION WAS UNABLE TO BE CLEARED. AN UNDERWATER LEAK TEST OF THE BALLOON, CATHETER, Y-FITTING AND EXTRACORPOREAL TUBING WAS PERFORMED AND A LEAK WAS DETECTED ON THE MEMBRANE APPROXIMATELY 0.8CM FROM THE REAR SEAL MEASURING 0.013CM IN LENGTH. ADDITIONALLY MULTIPLE LEAKS AROUND THE MEMBRANE WERE DETECTED AT THE SAME LOCATION APPROXIMATELY 9.9CM FROM THE REAR SEAL AND ALL MEASURING APPROXIMATELY 0.152CM IN LENGTH. THE REPORTED PROBLEM WAS MOST LIKELY TRIGGERED BY LEAKS WHICH WERE FOUND ON THE MEMBRANE. THE PENETRATIONS FOUND ON THE MEMBRANE APPEARS TO HAVE BEEN CAUSED BY A SHARP OBJECT. WE ARE UNABLE TO DETERMINE WHEN THIS OCCURRED. 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).
THE PRODUCT WAS RETURNED WITH THE MEMBRANE COMPLETELY UNFOLDED AND BLOOD ON THE INTERIOR AND EXTERIOR OF THE CATHETER AND BETWEEN THE CATHETER AND THE SHEATH. THE RETURNED SHEATH WAS NOT A MAQUET PRODUCT. THE OPTICAL FIBER WAS FOUND TO BE BROKEN WITHIN THE MEMBRANE APPROXIMATELY 1.8CM FROM IAB TIP. THE INNER LUMEN WAS FOUND OCCLUDED WITH DRIED BLOOD. THE OCCLUSION WAS UNABLE TO BE CLEARED. AN UNDERWATER LEAK TEST OF THE BALLOON, CATHETER, Y-FITTING AND EXTRACORPOREAL TUBING WAS PERFORMED AND A LEAK WAS DETECTED ON THE MEMBRANE APPROXIMATELY 0.8CM FROM THE REAR SEAL MEASURING 0.013CM IN LENGTH. ADDITIONALLY MULTIPLE LEAKS AROUND THE MEMBRANE WERE DETECTED AT THE SAME LOCATION APPROXIMATELY 9.9CM FROM THE REAR SEAL AND ALL MEASURING APPROXIMATELY 0.152CM IN LENGTH. THE REPORTED PROBLEM WAS MOST LIKELY TRIGGERED BY LEAKS WHICH WERE FOUND ON THE MEMBRANE. THE PENETRATIONS FOUND ON THE MEMBRANE APPEARS TO HAVE BEEN CAUSED BY A SHARP OBJECT. WE ARE UNABLE TO DETERMINE WHEN THIS OCCURRED. 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 NAME - (B)(6) HOSPITAL. EVENT SITE POSTAL CODE - (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. COMPLAINT RECORD ID # (B)(4).
THIS EVENT OCCURRED ON THE JAPANESE MARKET WITH A TRANSRAY 40CC IAB, WHICH IS A SIGNIFICANTLY SIMILAR DEVICE TO SENSATION 40CC WHICH IS SOLD IN THE US. FOR D4: DI NUMBER HAS BEEN USED FOR SENSATION 40CC (B)(4), WHICH IS SOLD IN THE USA. PROVIDED D4 LOT NUMBER, D4 EXPIRATION DATE, AND H4 DEVICE MANUFACTURE DATE CORRESPONDING TO TRANSRAY DEVICE INVOLVED IN THE EVENT, WHICH IS NOT AVAILABLE IN USA.
THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER SO WE ARE UNABLE TO COMPLETE AN EVALUATION. REFERENCE COMPLAINT #(B)(4).
N/A.
IT WAS REPORTED THAT AFTER REMOVAL OF AN INTRA-AORTIC BALLOON (IAB), A BLOOD CLOT WAS SEEN INSIDE THE IAB. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.
N/A.
N/A.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1617598 | TRANSRAY PLUS 7.5FR. 40CC IAB | SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL | DSP | DATASCOPE CORP. | 3000320635 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | UNKNOWN. |