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 2020-03-20 for STEERABLE GUIDE CATHETER SGC0302 manufactured by Abbott Vascular.
[187407128]
The device was returned. Investigation is not yet complete. A follow up report will be submitted with all relevant information.
Patient Sequence No: 1, Text Type: N, H10
[187407129]
This is being filed to report leak, crack, and medical intervention. It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4. It was noted sub-optimal transseptal puncture. The first clip was successfully deployed. Then when advancing the second clip delivery system (cds) into the steerable guide catheter (sgc), loss of fluid column was observed and air entered the outside part of the sgc. Additional aspirations were performed and both the cds and sgc were removed from the patient. The devices were inspected and it was observed that the hemostatic valve of the sgc was cracked which resulted in air leakage, and the clip would not open. Therefore, the procedure continued with a new sgc and a new cds. Two clips were implanted, reducing mr to 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 | 2024168-2020-02762 |
| MDR Report Key | 9862900 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-20 |
| Date of Report | 2020-03-20 |
| Date of Event | 2020-03-02 |
| Date Mfgr Received | 2020-03-02 |
| Device Manufacturer Date | 2019-11-18 |
| 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 |
| Returned To Mfg | 2020-03-20 |
| Catalog Number | SGC0302 |
| Lot Number | 91118U134 |
| 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 | 2020-03-20 |