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 2020-03-24 for STEERABLE GUIDE CATHETER SGC0301 manufactured by Abbott Vascular.
[188010840]
The device was not returned for evaluation. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot. Based on the information reviewed, a definitive cause for the reported thrombosis and embolism could not be determined in this event. The reported patient effects of embolism and thrombus as listed in the mitraclip system instructions for use are a known possible complication associated with mitraclip procedures. Although a conclusive cause for the reported patient effects and the relationship to the device, if any, cannot be determined, there is no indication of a product quality issue with respect to manufacture, design or labeling.
Patient Sequence No: 1, Text Type: N, H10
[188010841]
This is being filed to report thrombosis and medical intervention. It was reported that this was a mitraclip procedure to treat mixed mitral regurgitation (mr) with a grade of 4+. A steerable guide catheter (sgc) was advanced to the mitral valve, and the first clip was deployed, reducing mr. Then when inserting the second clip delivery system (cds), a clot was observed on the sgc, in the left and right atrium. The cds was removed and aspirations were performed. The patient was given medication. Then when the sgc was removed, the thrombus was gone. It was suspected that the thrombus embolized, but this could not be confirmed. The procedure was aborted. The patient is stable. One clip was implanted, reducing mr to 2-3. There were no adverse patient effects and no clinically significant delay in the procedure.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 2024168-2020-02812 |
MDR Report Key | 9874234 |
Report Source | COMPANY REPRESENTATIVE,HEALTH |
Date Received | 2020-03-24 |
Date of Report | 2020-03-24 |
Date of Event | 2020-03-04 |
Date Mfgr Received | 2020-03-04 |
Device Manufacturer Date | 2020-01-02 |
Date Added to Maude | 2020-03-24 |
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 | 2020-03-24 |
Model Number | SGC0301 |
Catalog Number | SGC0301 |
Lot Number | 00102U156 |
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 | 2020-03-24 |