MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2020-03-11 for HST III SYSTEM (3.8MM) HSK-3038 manufactured by Maquet Cardiovascular Llc.
[185712774]
Trackwise id# (b)(4). A lot history record review was completed for the reported product lot number. There were no ncmr? S for the reported lot number. The device has been returned to the factory and is being evaluated. A supplemental report will be submitted when the evaluation is completed.
Patient Sequence No: 1, Text Type: N, H10
[185712775]
The hospital reported that during a coronary artery bypass procedure using hs iii proximal seal sytem 3. 8mm , after sealing the handle normally,the seal was inserted into the aorta hole, but the seal did not unfold in the shape of an umbrella. A replacement device was used to complete the procedure. The hospital did not report any patient effects.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2242352-2020-00229 |
| MDR Report Key | 9821863 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2020-03-11 |
| Date of Report | 2020-03-25 |
| Date of Event | 2020-02-17 |
| Date Mfgr Received | 2020-03-18 |
| Device Manufacturer Date | 2019-07-02 |
| Date Added to Maude | 2020-03-11 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Street | 45 BARBOUR POND DRIVE |
| Manufacturer City | WAYNE NJ 07470 |
| Manufacturer Country | US |
| Manufacturer Postal | 07470 |
| Manufacturer G1 | MAQUET CARDIOVASCULAR LLC |
| Manufacturer Street | 45 BARBOUR POND DRIVE |
| Manufacturer City | WAYNE NJ 07470 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07470 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HST III SYSTEM (3.8MM) |
| Generic Name | CLAMP, VASCULAR |
| Product Code | DXC |
| Date Received | 2020-03-11 |
| Returned To Mfg | 2020-03-02 |
| Model Number | HST III SYSTEM (3.8MM) |
| Catalog Number | HSK-3038 |
| Lot Number | 25147144 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAQUET CARDIOVASCULAR LLC |
| Manufacturer Address | 45 BARBOUR POND DRIVE WAYNE NJ 07470 US 07470 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-11 |