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 2020-03-11 for STEERABLE GUIDE CATHETER SGC0302 manufactured by Abbott Vascular.
[184448189]
The device was not returned for analysis. A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot. Based on the information reviewed, a conclusive cause for the reported pericardial effusion cannot be determined. The reported patient effect of pericardial effusion as listed in the mitraclip system instructions for use (ifu), is a known possible complication associated with mitraclip procedures. There is no indication of a product issue with respect to manufacture, design or labeling.
Patient Sequence No: 1, Text Type: N, H10
[184448190]
This is being filed to report the pericardial effusion. It was reported that this was a mitraclip procedure to treat mixed mitral regurgitation (mr) with a grade of 4. One clip was implanted, reducing mr to 1-2. After the procedure, a pericardial effusion was noted at the right apex. The patient was monitored for 10 minutes and the effusion nearly disappeared. There was no clinically significant delay in the procedure and no adverse patient sequela. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024168-2020-02285 |
| MDR Report Key | 9819933 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-11 |
| Date of Report | 2020-03-11 |
| Date of Event | 2020-02-24 |
| Date Mfgr Received | 2020-02-24 |
| Device Manufacturer Date | 2019-12-09 |
| Date Added to Maude | 2020-03-11 |
| 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 | 2020-03-11 |
| Catalog Number | SGC0302 |
| Lot Number | 91207U233 |
| 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 | 1. Other | 2020-03-11 |