MEGA 7.5FR. 40CC
Report
- Report Number
- 2248146-2020-00079
- Event Type
- Malfunction
- Date Received
- February 10, 2020
- Date of Event
- January 17, 2020
- Report Date
- June 9, 2020
- Manufacturer
- DATASCOPE CORP. - FAIRFIELD
- Product Code
- DSP
- PMA / PMN Number
- K120868
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- PHYSICIAN
Narratives
THE PRODUCT WAS RETURNED WITH THE MEMBRANE PARTIALLY UNFOLDED WITH TRACES OF BLOOD ON THE EXTERIOR OF THE CATHETER. NO PHYSICAL DAMAGE NOTED. AN UNDERWATER LEAK TEST OF THE BALLOON, CATHETER, Y-FITTING AND EXTRACORPOREAL TUBING WAS PERFORMED AND NO LEAKS WERE DETECTED. THE REPORTED EVENT CANNOT BE CONFIRMED BY THE EVALUATION. WE ARE UNABLE TO DUPLICATE THE CLINICAL SETTINGS. THE REPORTED LEAK LIKELY RESULTED FROM A CONDITION KNOWN AS ¿CHANNELING¿. ARTERIAL BLOOD UNDER PRESSURE MAY RUN THE LENGTH OF THE FOLDS IN THE BALLOON MEMBRANE AND DRIP OR BE EXPELLED UNDER ARTERIAL PRESSURE FROM THE BALLOON/CATHETER JUNCTION. THIS "CHANNELING" IS NOT A LEAK AND WILL DIMINISH AS THE IAB CATHETER IS INSERTED. 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. (B)(4).
CORRECTED SECTION: G5 - 'PMA/510(K)#' WAS LEFT BLANK ON INITIAL EMDR. SHOULD BE K120868. 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. (B)(4).
CORRECTION FOR EMDR FOLLOW UP # (B)(4) (MFG REPORT NUMBER 2248146-2020-00079) SECTION G4 - DATE RECEIVED BY MFG CHANGED FROM 1/21/2020 TO 3/5/2020. COMPLAINT #(B)(4).
ADDITIONAL INFORMATION CHANGED DEVICE AVAILABLE FOR EVAL? NO TO YES. RETURN TO MANUFACTURE DATE - 04/07/2020 EVALUATION RESULT CODES UPDATED & EVALUATION CONCLUSION CODES UPDATED DEVICE NOT EVAL PROVIDE CODE 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 DURING INTRA-AORTIC BALLOON (IAB) THERAPY, THE BALLOON WAS INSERTED NORMALLY. HOWEVER, AFTER PUMPING FOR A FEW MINUTES, BLOOD WAS FOUND IN THE TUBING. THE BALLOON WAS REMOVED AND A NEW ONE WAS INSERTED. THERE WAS NO REPORTED INJURY TO THE PATIENT.
IT WAS REPORTED THAT DURING INTRA-AORTIC BALLOON (IAB) THERAPY, THE BALLOON WAS INSERTED NORMALLY. HOWEVER, AFTER PUMPING FOR A FEW MINUTES, BLOOD WAS FOUND IN THE TUBING. THE BALLOON WAS REMOVED AND A NEW ONE WAS INSERTED. THERE WAS NO REPORTED INJURY TO THE PATIENT.
IT WAS REPORTED THAT DURING INTRA-AORTIC BALLOON (IAB) THERAPY, THE BALLOON WAS INSERTED NORMALLY. HOWEVER, AFTER PUMPING FOR A FEW MINUTES, BLOOD WAS FOUND IN THE TUBING. THE BALLOON WAS REMOVED AND A NEW ONE WAS INSERTED. THERE WAS NO REPORTED INJURY TO THE PATIENT.
IT WAS REPORTED THAT DURING INTRA-AORTIC BALLOON (IAB) THERAPY, THE BALLOON WAS INSERTED NORMALLY. HOWEVER, AFTER PUMPING FOR A FEW MINUTES, BLOOD WAS FOUND IN THE TUBING. THE BALLOON WAS REMOVED AND A NEW ONE WAS INSERTED. THERE WAS NO REPORTED INJURY TO THE PATIENT.
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 DURING INTRA-AORTIC BALLOON (IAB) THERAPY, THE BALLOON WAS INSERTED NORMALLY. HOWEVER, AFTER PUMPING FOR A FEW MINUTES, BLOOD WAS FOUND IN THE TUBING. THE BALLOON WAS REMOVED AND A NEW ONE WAS INSERTED. THERE WAS NO REPORTED INJURY TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 152562 | MEGA 7.5FR. 40CC | SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL | DSP | DATASCOPE CORP. - FAIRFIELD | 3000101012 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR |