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 2020-03-26 for HSK III SYSTEM (3.8MM) HST III SYSTEM (3.8MM) HSK-3038 manufactured by Maquet Cardiovascular Llc.
[187304857]
(b)(4). A photographic inspection was conducted. A photo of the product information with the lot number and the delivery device inside the loading device with blood covering both devices, the aortic cutter inside the plastic tray. The device was returned to the factory with the cutter on 12mar2020 for evaluation and investigated on 02apr2020. A visual inspection was conducted. The delivery device, loading device, aortic cutter and seal with tension spring assembly were returned. The delivery device was returned outside of the loading device. Traces of blood was observed on the aortic cutter. The safety lock on the cutter was engaged and the actuation button was not fully depressed inside the tool with the cutter and spiral needle not fully deploying. Signs of clinical use and heavy amounts of blood was observed on the loading device, delivery device, and seal. The blue slide lock was dis-engaged and the plunger was completely depressed. The anchor and tension spring assembly remained inside the delivery device with the seal hanging outside the delivery tube indicating that the deployment was successful. The seal was extended outside the tube and did not appear to be folded. The seal was removed from the delivery tube. The seal was inspected. The seal doesn't appear to have any cracks/delamination. The tether remained uncut and attached to the seal and tension spring. Measurements were unable to be taken; the inner delivery tube contained a heavy amount of dried blood. Based on the returned condition of the device, the reported failure "failure to unfold or unwrap" was not confirmed. Based on the returned condition of the device, there were no abnormalities found with the seal. It was also found that the seal was deployed into the aorta in the correct orientation. Therefore, the failure "leak" could not be confirmed.
Patient Sequence No: 1, Text Type: N, H10
[187304858]
The hospital reported that during a coronary artery bypass procedure, hst iii system (3. 8mm) seal came out and had a lot of bleeding. 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 | 2242352-2020-00292 |
| MDR Report Key | 9882113 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-24 |
| Date of Event | 2020-03-02 |
| Date Mfgr Received | 2020-03-03 |
| Device Manufacturer Date | 2019-10-17 |
| Date Added to Maude | 2020-03-26 |
| 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 SYSTEM (3.8MM) |
| Generic Name | CLAMP, VASCULAR |
| Product Code | DXC |
| Date Received | 2020-03-26 |
| Returned To Mfg | 2020-03-12 |
| Model Number | HST III SYSTEM (3.8MM) |
| Catalog Number | HSK-3038 |
| Lot Number | 25148558 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| 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 | 1. Required No Informationntervention | 2020-03-26 |