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 2020-03-20 for STEERABLE GUIDE CATHETER SGC0301 manufactured by Abbott Vascular.
[184437347]
The customer reported the device was discarded. 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
[184437348]
This is filed to report a leak. It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4+. The steerable guide catheter (sgc) was inserted but was unable to cross the transseptal due to a very compliant septum. It was noted that a balloon was used on two occasion in an attempt to advance the sgc into the left atrium (la), but was unsuccessful. After three prior attempts to cross the septum, air was noticed during the fourth preparation of the sgc as it was no longer holding fluid column. The sgc was not reentered into the patient. It was noted that no air was in the device during the first three attempts to cross the septum. A new sgc inserted and was able to cross the septum and reach the la. One clip was successfully implanted, reducing mr to a grade of 1-2. There were no adverse patient effects and no clinically significant delay in the procedure. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024168-2020-02695 |
| MDR Report Key | 9860179 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-20 |
| Date of Report | 2020-03-20 |
| Date of Event | 2020-02-27 |
| Date Mfgr Received | 2020-02-27 |
| Device Manufacturer Date | 2019-12-13 |
| Date Added to Maude | 2020-03-20 |
| 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 | 2020-03-20 |
| Model Number | SGC0301 |
| Catalog Number | SGC0301 |
| Lot Number | 91213U120 |
| 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 | 2020-03-20 |