MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-16 for HSK III SEAL (4.5MM) HST III SEAL (4.5MM), 5-PACK HS-3045 manufactured by Maquet Cardiovascular Llc.
[185493514]
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
[185493515]
The hospital reported that during a coronary artery bypass procedure using hst iii seal (4. 5mm). After performing the operation of pushing the pressurized system to the developing system and inserting the developing system into the aorta (after using the actuator), the opening of the aorta could not be completely closed by the pressurized system. Judged that the push-through was poorly deployed, the surgeon judged that there was a problem, and removed the pressure seal with the condition spring remaining in the tube of the vacuum system. (thus, it is possible that sufficient pressure adjustment was not performed on the pressure seal. ) hospital saw bleeding for a moment, but pressed the opening with finger and kept it to a minimum. 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 | 2242352-2020-00239 |
| MDR Report Key | 9837080 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-16 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-02-19 |
| Date Mfgr Received | 2020-03-18 |
| Device Manufacturer Date | 2019-05-07 |
| Date Added to Maude | 2020-03-16 |
| 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 | HSK III SEAL (4.5MM) |
| Generic Name | CLAMP, VASCULAR |
| Product Code | DXC |
| Date Received | 2020-03-16 |
| Returned To Mfg | 2020-03-11 |
| Model Number | HST III SEAL (4.5MM), 5-PACK |
| Catalog Number | HS-3045 |
| Lot Number | 25146430 |
| 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 | 2020-03-16 |