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 2020-03-12 for STEERABLE GUIDE CATHETER SGC0301 manufactured by Abbott Vascular.
[186122246]
The device was not returned for analysis. A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to this event. The patient effects of hypotension and pericardial effusion, as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures. A definitive cause for the reported pericardial effusion could not be determined; however, the reported hypotension was due to the reported pericardial effusion. Although a conclusive cause for the reported patient effects of hypotension, pericardial effusion and the relationship to the device, if any, cannot be determined, there is no indication of a product issue with respect to manufacture, design, or labeling.
Patient Sequence No: 1, Text Type: N, H10
[186122247]
This is filed to report the pericardial effusion. It was reported this was a mitraclip procedure to treat grade 3 mixed mitral regurgitation (mr). After the steerable guide catheter (sgc) was inserted a small pericardial effusion was noted. The patients? Blood pressure dropped; medication was used for treatment for the effusion and hypotension. The procedure was aborted. No clips were implanted, mr remains at a grade of 3. Per the physician, it is unknown if the effusion was caused by the guide wire or the sgc. No additional treatment is planned for the patient. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024168-2020-02391 |
| MDR Report Key | 9826648 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-12 |
| Date of Report | 2020-03-12 |
| Date of Event | 2020-02-19 |
| Date Mfgr Received | 2020-02-19 |
| Device Manufacturer Date | 2019-12-03 |
| 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 |
| Model Number | SGC0301 |
| Catalog Number | SGC0301 |
| Lot Number | 91202U215 |
| 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. Required No Informationntervention | 2020-03-12 |