MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a literature report with the FDA on 2020-03-10 for STEERABLE GUIDE CATHETER UNK SGC03 manufactured by Abbott Vascular.
[182776396]
Date of event is estimated. The devices were not returned for analysis and a review of the lot history record could not be performed as the part and lot information regarding the complaint device was not provided. A definitive cause for the reported atrial perforation could not be determined. The patient effect of atrial perforation, as listed in the mitraclip system instructions for use, is a known possible complications associated with mitraclip procedures. A conclusive cause for the reported patient effect of atrial perforation, 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. The clip delivery system (cds) referenced is filed under a separate medwatch report number.
Patient Sequence No: 1, Text Type: N, H10
[182776397]
This is filed to report an atrial septal defect (asd). It was reported that in (b)(6) of 2014, a mitraclip procedure was performed to treat mitral regurgitation (mr). Three mitraclip were successfully implanted; however, mr was only slightly reduced. 11 days later, echocardiogram showed mr had increased; therefore, mitral valve replacement was performed. During the mitral valve replacement, a closure device was used to close the atrial septal defect (asd). Once the clips were removed, it was noted that extensive tissue damage had occurred to the leaflets. The patient was in good health after the procedure. For additional information, see attached article.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024168-2020-02193 |
| MDR Report Key | 9811328 |
| Report Source | LITERATURE |
| Date Received | 2020-03-10 |
| Date of Report | 2020-03-10 |
| Date of Event | 2014-02-01 |
| Date Mfgr Received | 2020-02-17 |
| Date Added to Maude | 2020-03-10 |
| 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 | 2020-03-10 |
| Catalog Number | UNK SGC03 |
| 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. Hospitalization; 2. Required No Informationntervention | 2020-03-10 |