TRANS-RAY PLUS 7.5 FR. 40CC IAB
Report
- Report Number
- 2248146-2019-00554
- Event Type
- Death
- Date Received
- June 24, 2019
- Date of Event
- May 28, 2019
- Report Date
- September 27, 2019
- Manufacturer
- DATASCOPE CORP. - FAIRFIELD
- Product Code
- DSP
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
CHANGED BRAND NAME FROM YAMATO PLUS-R 7.5FR. 30CC IAB TO TRANS-RAY PLUS 7.5 FR. 40CC IAB CHANGED LOT # FROM 3000072337 TO 3000081527. CHANGED EXPIRATION DATE FROM 09/07/2021 TO 9/28/2021. CHANGED CATALOG # FROM 0684-00-0549-01 TO 0684-00-0605. CHANGED MANUFACTURE DATE FROM 09/07/2018 TO 9/28/2018. THE PRODUCT WAS RETURNED WITH THE MEMBRANE COMPLETELY UNFOLDED WITH TRACES OF BLOOD ON THE EXTERIOR OF THE CATHETER AND BETWEEN THE CATHETER AND THE SHEATH. A VISUAL EXAMINATION OF THE PRODUCT DETECTED THE INNER LUMEN WITHIN THE MEMBRANE WAS COMPLETELY SEPARATED WITHIN A KINK APPROXIMATELY 23.6CM FROM IAB TIP. TWO ADDITIONAL KINKS WERE FOUND, ONE ON THE INNER LUMEN APPROXIMATELY 21.3CM FROM THE IAB TIP AND THE OTHER ON THE CATHETER TUBING APPROXIMATELY 51.6CM FROM THE IAB TIP. AN UNDERWATER LEAK TEST OF THE BALLOON, CATHETER, Y-FITTING AND EXTRACORPOREAL TUBING WAS PERFORMED AND NO OTHER LEAKS WERE DETECTED. THE BREAK FOUND IN THE INNER LUMEN APPEARS TO HAVE BEEN THE RESULT OF A SEVERE KINK, WHICH EVENTUALLY FAILED AND ALLOWED BLOOD TO LEAK INTO THE MEMBRANE AND CATHETER TUBING CAUSING THE REPORTED PROBLEMS. IT IS DIFFICULT TO DETERMINE WHEN THE BREAK OCCURRED BUT IT IS POSSIBLY A RESULT OF PATIENT MOVEMENT DURING THE PROCEDURE. A DEVICE AND LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT. NO NONCONFORMANCES WERE FOUND THAT ARE CONSIDERED TO BE RELATED TO THE EVENT. COMPLAINT # (B)(4).
THE PRODUCT HAS BEEN RETURNED TO THE MANUFACTURER, BUT IS PENDING INVESTIGATION. ONCE THE INVESTIGATION IS COMPLETED A SUPPLEMENTAL REPORT WITH OUR FINDINGS WILL BE SUBMITTED. COMPLAINT # (B)(4).
IT WAS REPORTED THAT THE PATIENT WAS TRANSFERRED TO THE HOSPITAL FROM ANOTHER FACILITY. ALTHOUGH PERCUTANEOUS CARDIOPULMONARY SUPPORT (PCPS) WAS PERFORMED, RESUSCITATION WAS UNSUCCESSFUL. INTRA-AORTIC BALLOON (IAB) THERAPY STARTED, HOWEVER, THE PATIENT¿S ATRIAL PULSE COULD NOT BE OBTAINED AND AN AUTOMATED EXTERNAL DEFIBRILLATOR (LUCAS MANUFACTURED BY PHYSIO-CONTROL, INC.) WAS USED. AFTER A FEW MINUTES OF BALLOON USE, BLOOD WAS OBSERVED WITHIN THE IAB CATHETER. THE IAB CATHETER WAS REMOVED FROM THE PATIENT AND IAB THERAPY WAS DISCONTINUED. LATER ON, THE PATIENT WAS NOT EXPECTED TO BE RESUSCITATED AND EXPIRED ON THE SAME DAY. THE FACILITY DOES NOT ATTRIBUTE THE DEATH TO THE DEVICE.
IT WAS REPORTED THAT THE PATIENT WAS TRANSFERRED TO THE HOSPITAL FROM ANOTHER FACILITY. ALTHOUGH PERCUTANEOUS CARDIOPULMONARY SUPPORT (PCPS) WAS PERFORMED, RESUSCITATION WAS UNSUCCESSFUL. INTRA-AORTIC BALLOON (IAB) THERAPY STARTED, HOWEVER, THE PATIENT¿S ATRIAL PULSE COULD NOT BE OBTAINED AND AN AUTOMATED EXTERNAL DEFIBRILLATOR (LUCAS MANUFACTURED BY PHYSIO-CONTROL, INC.) WAS USED. AFTER A FEW MINUTES OF BALLOON USE, BLOOD WAS OBSERVED WITHIN THE IAB CATHETER. THE IAB CATHETER WAS REMOVED FROM THE PATIENT AND IAB THERAPY WAS DISCONTINUED. LATER ON, THE PATIENT WAS NOT EXPECTED TO BE RESUSCITATED AND EXPIRED ON THE SAME DAY. THE FACILITY DOES NOT ATTRIBUTE THE DEATH TO THE DEVICE.
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).
DATE OF EVENT BEING CHANGED FROM (B)(6) 2019 TO (B)(6) 2019 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).
IT WAS REPORTED THAT THE PATIENT WAS TRANSFERRED TO THE HOSPITAL FROM ANOTHER FACILITY. ALTHOUGH PERCUTANEOUS CARDIOPULMONARY SUPPORT (PCPS) WAS PERFORMED, RESUSCITATION WAS UNSUCCESSFUL. INTRA-AORTIC BALLOON (IAB) THERAPY STARTED, HOWEVER, THE PATIENT¿S ATRIAL PULSE COULD NOT BE OBTAINED AND AN AUTOMATED EXTERNAL DEFIBRILLATOR (LUCAS MANUFACTURED BY PHYSIO-CONTROL, INC.) WAS USED. AFTER A FEW MINUTES OF BALLOON USE, BLOOD WAS OBSERVED WITHIN THE IAB CATHETER. THE IAB CATHETER WAS REMOVED FROM THE PATIENT AND IAB THERAPY WAS DISCONTINUED. LATER ON, THE PATIENT WAS NOT EXPECTED TO BE RESUSCITATED AND EXPIRED ON THE SAME DAY. THE FACILITY DOES NOT ATTRIBUTE THE DEATH TO THE DEVICE.
IT WAS REPORTED THAT THE PATIENT WAS TRANSFERRED TO THE HOSPITAL FROM ANOTHER FACILITY. ALTHOUGH PERCUTANEOUS CARDIOPULMONARY SUPPORT (PCPS) WAS PERFORMED, RESUSCITATION WAS UNSUCCESSFUL. INTRA-AORTIC BALLOON (IAB) THERAPY STARTED, HOWEVER, THE PATIENT¿S ATRIAL PULSE COULD NOT BE OBTAINED AND AN AUTOMATED EXTERNAL DEFIBRILLATOR (LUCAS MANUFACTURED BY PHYSIO-CONTROL, INC.) WAS USED. AFTER A FEW MINUTES OF BALLOON USE, BLOOD WAS OBSERVED WITHIN THE IAB CATHETER. THE IAB CATHETER WAS REMOVED FROM THE PATIENT AND IAB THERAPY WAS DISCONTINUED. LATER ON, THE PATIENT WAS NOT EXPECTED TO BE RESUSCITATED AND EXPIRED ON THE SAME DAY. THE FACILITY DOES NOT ATTRIBUTE THE DEATH TO THE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 520212 | TRANS-RAY PLUS 7.5 FR. 40CC IAB | SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL | DSP | DATASCOPE CORP. - FAIRFIELD | 3000081527 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death | EXTERNAL DEFIBRILLATOR LUCAS| EXTERNAL DEFIBRILLATOR LUCAS| EXTERNAL DEFIBRILLATOR LUCAS| EXTERNAL DEFIBRILLATOR LUCAS| EXTERNAL DEFIBRILLATOR LUCAS |