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 2020-03-24 for STEERABLE GUIDE CATHETER SGC0302 manufactured by Abbott Vascular.
[187172425]
The additional device mentioned will be filed under a separate medwatch report. The device was returned. 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
[187172426]
This is being filed to report the leak requiring intervention. It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4. The clip delivery system (cds) was advanced to the anatomy when a leak was noted from the delivery catheter (dc) handle and a bubble was noted on the echo imaging. The dc cap was removed and filled with water. The cds was advanced back to the mitral valve and the clip deployed, reducing mr to 2. The cds was being retracted into the steerable guide catheter (sgc) and aspiration was performed with a syringe when air was noted coming into the syringe. The sgc was pulled back to the right atrium and the cds removed. The hemostasis valve on the sgc was sealed with the physicians thumb and aspiration performed. Blood was noted aspirating from the sgc. The procedure was completed with 1 clip implanted, reducing mr to 2. There was no clinically significant delay in the procedure and no adverse patient effects. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024168-2020-02804 |
| MDR Report Key | 9873868 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| 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 | 2019-09-27 |
| 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 |
| Returned To Mfg | 2020-03-23 |
| Catalog Number | SGC0302 |
| Lot Number | 90926U209 |
| 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 | 1. Required No Informationntervention | 2020-03-24 |