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 2020-03-12 for STEERABLE GUIDE CATHETER SGC0301 manufactured by Abbott Vascular.
[183125404]
The device was not returned for analysis. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot. Additionally, a review of the complaint history identified no similar complaints reported from this lot. All available information was investigated and the reported difficult to insert (anatomy) was a result of challenging anatomy and operational context. The reported deformation due to compressive stress (shaft) was a cascading result of the reported difficult to insert (anatomy). The reported cable break was a result of operational context as it was reported that the negative knob was overrotated once the sgc was removed from the anatomy. The reported audible noise was due to the reported cable break. There is no indication of product quality issue with respect to manufacture, design or labeling.
Patient Sequence No: 1, Text Type: N, H10
[183125405]
This is being filed to report the cable break. It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4. Resistance was met inserting the steerable guide catheter (sgc) into the femoral vein, resulting in a kink. The sgc was removed. The negative knob was turned past? And a pop was heard, the cable was noted to be broken. The sgc was replaced with a new one and two clips were implanted, reducing mr to 2. There was no clinically significant delay in the procedure and no adverse patient effects.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024168-2020-02308 |
| MDR Report Key | 9823525 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-12 |
| Date of Report | 2020-03-12 |
| Date of Event | 2020-02-19 |
| Date Mfgr Received | 2020-02-19 |
| Device Manufacturer Date | 2019-12-16 |
| Date Added to Maude | 2020-03-12 |
| 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 | 2020-03-12 |
| Model Number | SGC0301 |
| Catalog Number | SGC0301 |
| Lot Number | 91216U115 |
| 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 | 2020-03-12 |