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 2020-03-31 for CDS06 CDS0602-NTR manufactured by Abbott Vascular.
[189056815]
The device is expected to be returned for investigation. It has not yet been received. A follow-up report will be submitted with all additional relevant information.
Patient Sequence No: 1, Text Type: N, H10
[189056816]
This is being filed to report the leak requiring aspiration. It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4+. The steerable guide catheter (sgc) was introduced into the left atrium (la) and the clip delivery system (cds) inserted into the sgc. Air bubbles were noted in the sgc distal to the hemostasis valve. The cds was removed and the air aspirated with a syringe. The cds was introduced again but the same issue occurred. The sgc was removed and replaced with a new one and the same cds reinserted but the same issue occurred, air was noted. It was noted the clip introducer was causing the air. Aspiration was performed and the cds was removed and replaced with a new one to complete the procedure, reducing mr to 2. There was no clinically significant delay in the procedure and no adverse patient effects. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024168-2020-03150 |
| MDR Report Key | 9905430 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-03-17 |
| Date Mfgr Received | 2020-03-17 |
| Device Manufacturer Date | 2019-11-14 |
| 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 | CDS06 |
| Generic Name | VALVE REPAIR |
| Product Code | NKM |
| Date Received | 2020-03-31 |
| Catalog Number | CDS0602-NTR |
| Lot Number | 91113U260 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| 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 | 1. Required No Informationntervention | 2020-03-31 |