MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-31 for MITRACLIP? SYSTEM CLIP DELIVERY SYSTEM CDS0601-XTR manufactured by Abbott Vascular.
[186380491]
The device was received. Investigation is not yet complete. A follow up report will be submitted with all relevant information.
Patient Sequence No: 1, Text Type: N, H10
[186380492]
This is filed for leak. It was reported that the clip delivery system (cds) packaging was opened and it was noted that the red cap was off and loose in the box. The device was prepped and it was noted to be leaking at the "o" ring on the lock lever. No troubleshooting was performed, as the physician was uncomfortable using the device. There was no patient involvement and no clinically significant delay in procedure. No additional information was provided regarding this issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024168-2020-03177 |
| MDR Report Key | 9908393 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-03-10 |
| Date Mfgr Received | 2020-03-10 |
| Device Manufacturer Date | 2019-10-17 |
| Date Added to Maude | 2020-03-31 |
| 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 Contact | MS. LINDSEY BELL |
| Manufacturer Street | 26531 YNEZ RD. |
| Manufacturer City | TEMECULA CA 925914628 |
| Manufacturer Country | US |
| Manufacturer Postal | 925914628 |
| Manufacturer Phone | 9519143996 |
| Manufacturer G1 | ABBOTT VASCULAR, REG # 3005070406 |
| Manufacturer Street | 3885 BOHANNON DRIVE |
| Manufacturer City | MENLO PARK CA 94025 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94025 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MITRACLIP? SYSTEM CLIP DELIVERY SYSTEM |
| Generic Name | VALVE REPAIR |
| Product Code | NKM |
| Date Received | 2020-03-31 |
| Returned To Mfg | 2020-03-25 |
| Model Number | CDS0601-XTR |
| Catalog Number | CDS0601-XTR |
| Lot Number | 91017U160 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT VASCULAR |
| Manufacturer Address | 26531 YNEZ RD. TEMECULA CA 925914628 US 925914628 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-31 |