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 2020-03-17 for STEERABLE GUIDE CATHETER SGC0301 manufactured by Abbott Vascular.
[186735026]
The device was not returned for analysis. A review of the lot history record did not identify any manufacturing nonconformities issued to the reported lot. In this case, there was no reported device malfunction associated with the steerable guide catheter (sgc). Based on the information reviewed, a definite cause for the reported thrombosis could not be determined. The reported patient effect of thrombosis as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedures. There is no indication of a product quality issue with respect to manufacture, design or labeling.
Patient Sequence No: 1, Text Type: N, H10
[186735027]
This is being filed to report thrombosis. It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4. A steerable guide catheter (sgc) was advanced to the mitral valve; however, a clot was observed prior to the clip delivery system entering the patient. The thrombosis was not removed and treatment was not provided. The physician stated the thrombosis is not related to the sgc, but this cannot be confirmed. The sgc was removed and the procedure was aborted. No clips were implanted, and mr is 4. There was no clinically significant delay in the procedure. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024168-2020-02539 |
| MDR Report Key | 9842860 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-17 |
| Date of Report | 2020-03-17 |
| Date of Event | 2020-02-26 |
| Date Mfgr Received | 2020-02-26 |
| Device Manufacturer Date | 2019-11-12 |
| Date Added to Maude | 2020-03-17 |
| 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 | 2020-03-17 |
| Model Number | SGC0301 |
| Catalog Number | SGC0301 |
| Lot Number | 91112U248 |
| 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. Other | 2020-03-17 |