MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-02 for ANGIASSIST AA0608 manufactured by Angioadvancements, Llc.
[107098795]
Patient Sequence No: 1, Text Type: N, H10
[107098796]
During procedure using co2, it was noted that one of the syringes broke off in the 3-way stopcock, allowing air to get in. It was corrected right away before it was used on the pt. A new co2 set-up was obtained and used. This was an equipment issue. The tip of the syringe actually broke off into the stop cock. Once this was discovered, it was replaced with a new one and the case continued with no further problems. No injury to patient. Device was not sequestered and is not available for return.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7479405 |
| MDR Report Key | 7479405 |
| Date Received | 2018-05-02 |
| Date of Report | 2018-04-26 |
| Date of Event | 2017-12-12 |
| Report Date | 2018-04-26 |
| Date Reported to FDA | 2018-04-26 |
| Date Reported to Mfgr | 2018-04-26 |
| Date Added to Maude | 2018-05-02 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | 3 |
| Brand Name | ANGIASSIST |
| Generic Name | TUBING, PRESSURE AND ACCESSORIES |
| Product Code | BYX |
| Date Received | 2018-05-02 |
| Catalog Number | AA0608 |
| Lot Number | 7108 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ANGIOADVANCEMENTS, LLC |
| Manufacturer Address | SHELBY LANE NORTH FT MYERS FL 33917 US 33917 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-05-02 |