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 2020-03-12 for STEERABLE GUIDE CATHETER SGC0302 manufactured by Abbott Vascular.
[183125977]
(b)(4). The device was received. The investigation is not yet complete. A follow-up report will be submitted with all additional relevant information.
Patient Sequence No: 1, Text Type: N, H10
[183125978]
Revised. It was reported that the mitraclip procedure was performed to treat mixed mitral regurgitation with grade of 4. The patient had a small anatomy with small atrium, the septal puncture was a huge problem and the height over the valve was 3. 3 cm. The steerable guide catheter (sgc) was inserted and advanced into artery, per the instruction for use (ifu). The physician had to manipulate the clip delivery system (cds) to gain height to the mitral valve; therefore, more curves were applied to the cds than usual and tension was very high. Before clip deployment, the gripper line broke as due to too much tension. The procedure was aborted as the second cds would have the same issue. The cds with the clip attached and gripper line were removed. There were no clips implanted, mr remained at 4. There was no adverse patient effect and no clinically significant delay in the procedure. The cds was returned inside the sgc and analysis revealed that the sgc soft tip was torn. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024168-2020-02314 |
| MDR Report Key | 9823793 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-12 |
| Date of Report | 2020-03-12 |
| Date of Event | 2020-01-29 |
| Date Mfgr Received | 2020-02-18 |
| Device Manufacturer Date | 2018-11-14 |
| 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 |
| Returned To Mfg | 2020-02-25 |
| Catalog Number | SGC0302 |
| Lot Number | 81114U124 |
| Device Expiration Date | 2019-11-14 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| 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 |