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 2020-03-10 for STEERABLE GUIDE CATHETER SGC0301 manufactured by Abbott Vascular.
[182787890]
The device was not returned for analysis. A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot. There was no reported device malfunction associated with the steerable guide catheter (sgc). All available information was investigated, and the reported thrombosis was due to challenging patient anatomy. The patient effect of thrombosis , as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedures. Although a conclusive cause for the reported patient effect of thrombosis and the relationship to the device, if any, cannot be determined. There is no indication of a product issue with respect to manufacture, design, or labeling.
Patient Sequence No: 1, Text Type: N, H10
[182787891]
This is being filed to report thrombosis and delay. It was reported that this was a mitraclip procedure to treat mixed mitral regurgitation with a grade of 3+ a steerable guide catheter (sgc) was advancing into the left atrium; however, a clot formed on the sgc. An attempt was made to treat the clot by cleaning the sgc, but another clot formed on the sgc causing a clinically significant delay in the procedure. The sgc was removed and the clot came with the sgc. Additional heparin was administered and the procedure was aborted. There was no thrombosis in the patient. No clips were implanted, and mr is 3+. The patient is stable. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024168-2020-02216 |
| MDR Report Key | 9812612 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-10 |
| Date of Report | 2020-03-10 |
| Date of Event | 2020-02-19 |
| Date Mfgr Received | 2020-02-19 |
| Device Manufacturer Date | 2019-08-20 |
| Date Added to Maude | 2020-03-10 |
| 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 | STEERABLE GUIDE CATHETER |
| Generic Name | VALVE REPAIR |
| Product Code | DRA |
| Date Received | 2020-03-10 |
| Model Number | SGC0301 |
| Catalog Number | SGC0301 |
| Lot Number | 90820U117 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2020-03-10 |