| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN | SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL | DATASCOPE CORP. - MAHWAH | DSP | N/A | UNKNOWN | N/A | N | N |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-27 | 0 | 1. D |
Patient 1
THE PRODUCTION DEVICE HISTORY RECORD (DHR) FOR THIS INTRA-AORTIC BALLOON PUMP (IABP) UNIT WAS UNABLE TO BE REVIEWED AS WE WERE NOT ABLE TO OBTAIN THE SERIAL NUMBER FOR THE IABP ASSOCIATED WITH THIS COMPLAINT. 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. DEVICE NOT RETURNED.
Patient 1
PLEASE REFER TO MFG REPORT NUMBER 2248146-2020-00157 FOR THE RELATED INTRA-AORTIC BALLOON CATHETER. LAST APRIL, THE (B)(6) RECEIVED NEWS OF AN UNFORTUNATE EVENT REGARDING THE DEATH OF A (B)(6) YO MALE PATIENT. THE PATIENT WAS BEING TREATED FOR CORONARY ARTERY STENTING FOLLOWING AN MI. SHORTLY INTO THE PROCEDURE, FOLLOWING CONTRAST MEDIA INFUSION, GUIDEWIRE PLACEMENT AND BALLOON CATHETER ANGIOPLASTY, HE COMPLAINED OF BEING UNWELL (AND A ?BURNING SENSATION? IN HIS HEAD?) AND RAPIDLY DETERIORATED ON THE TABLE AND SUFFERED HEART FAILURE. IT IS SUGGESTED BY THE TREATING CARDIOLOGIST THAT THE PATIENT EXPERIENCED A SUDDEN DETERIORATION RELATED TO POSSIBLE ANAPHYLAXIS AND THAT THIS COULD BE HAVE BEEN INDUCED BY POLYETHYLENE GLYCOL (PEG) EXPOSURE. THE PATIENT HAD A PRIOR DIAGNOSIS OF ALLERGY TO PEG. IT IS NOT CLEAR WHETHER THE PATIENT SUFFERED A FATAL CARDIAC ARREST DUE TO THEIR EXISTING CARDIAC DISORDER AND TREATMENT, OR WHETHER THIS DETERIORATION WAS INDEED ANAPHYLAXIS AND DIRECTLY/INDIRECTLY BROUGHT ON BY EXPOSURE TO PEG. THE PATHOLOGIST HAS NOT RULED OUT THIS POSSIBILITY. RECENTLY, HM CORONER HAS PROVIDED MEDICAL RECORDS TO PROPERLY INTERESTED PERSONS INCLUDING (B)(6), AND IN THOSE MEDICAL RECORDS IS A PAGE ON ?EQUIPMENT BARCODES? AND DETAILS OF DEVICES USED TO TREAT THE PATIENT. ONE DEVICE IS LISTED TO BE A SENSATION PLUS 8 FR, 50CC IAB CATHETER MANUFACTURED BY GETINGE.