MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-27 for ACIST POWER SUPPLY manufactured by Acist Medical Systems, Inc..
[101346578]
Pt was at an outlying facility with complaints of chest pain. Pt was accepted to our facility for further treatment and evaluation of st elevation myocardial infarction. Cardiac cath team prepped the room for pt's arrival. The acist contrast injector was set up and primed in the normal process. Pt arrived to facility and was taken to the cath lab for an angiogram. Proceduralist obtained access through the right radial without difficulty. The catheter was inserted to the ascending aorta. The catheter was fully aspirated in standard fashion, contrast was advanced by acist device to the stopcock connected to the catheter and normal central aortic pressure wave was obtained. The tubing was filled with contrast and inspected in standard fashion, showing on air in tubing. The catheter was then flushed with contrast under fluoroscopy and advanced to the left main coronary ostium without difficulty with small test injections to guide engagement. Upon entering the left main, a small test injection (0. 5 ml) done under fluoroscopy showed a poor flow in left coronary system. As pressure was on catheter was good, 4 ml injection of contrast was performed, showing evidence of air embolism in the lad and left circumflex artery. Pt coded and needed to be resuscitated with impella, amiodarone, intubation, defibrillation and temporary pacemaker.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5075582 |
| MDR Report Key | 7302639 |
| Date Received | 2018-02-27 |
| Date of Report | 2018-02-26 |
| Date of Event | 2018-02-16 |
| Date Added to Maude | 2018-02-28 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ACIST POWER SUPPLY |
| Generic Name | ANGIOGRAPHIC INJECTION SYSTEM |
| Product Code | DXT |
| Date Received | 2018-02-27 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ACIST MEDICAL SYSTEMS, INC. |
| Manufacturer Address | EDEN PRAIRIE MN 55344 US 55344 |
| Brand Name | ACIST INJECTOR HEAD |
| Generic Name | INJECTOR, CONTRAST MEDIUM |
| Product Code | IZQ |
| Date Received | 2018-02-27 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | ACIST MEDICAL SYSTEMS, INC. |
| Manufacturer Address | EDEN PRAIRIE MN 55344 US 55344 |
| Brand Name | ACIST CONTROL PANEL |
| Generic Name | ANGIOGRAPHIC INJECTION SYSTEM |
| Product Code | DXT |
| Date Received | 2018-02-27 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 3 |
| Device Event Key | 0 |
| Manufacturer | ACIST MEDICAL SYSTEMS, INC. |
| Manufacturer Address | EDEN PRAIRIE MN 55344 US 55344 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention | 2018-02-27 |