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.
[187406172]
The device was not returned for analysis. A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot. In this case, there was no reported device malfunction associated with the steerable guide catheter (sgc). The reported patient effect of tissue damage, as listed in the mitraclip system instructions for is a known possible complication associated with mitraclip procedures. The investigation was unable to determine a cause for the reported the reported tissue damage. There is no indication of a product issue with respect to manufacture, design or labeling. The first clip, cds0502 80817u122, mentioned is filed under a separate medwatch report.
Patient Sequence No: 1, Text Type: N, H10
[187406173]
Patient id: (b)(6). This report is being filed due to possible device related tissue injury. It was reported that on (b)(6) 2018, the patient presented with ischemic functional mitral regurgitation (mr) grade 4+, and leaflet tethering. The steerable guide catheter (sgc) was placed without any unusual resistance. It was possible that septal tissue possibly attached to the sgc. Mitraclip, cds0502 80817u122, advanced to the left atrium, without any unusual resistance, when septal tissue on the clip was observed. The clip as removed without reported issues and not implanted. Reportedly, it is unknown if the clip, cds0502 80817u122, or the sgc damaged the tissue. Another mitraclip (cds0502 80810u133) was implanted without a device issue, reducing the mr to grade 2+. On (b)(6) 2018, a follow-up echocardiogram was performed and the mr was graded 3+. Per physician, the increase in mr was due to disease progression. There was no device issue. The implanted clip (cds0502 80810u133) had remained stable and well seated without tissue injury. On (b)(6) 2019, the patient was hospitalized for a worsening of their pre-existing heart failure. Medications were provided. During this hospitalization and on (b)(6) 2019, the patient expired due to heart failure. Per physician, the events were unrelated to the mitraclip device and unrelated to the mitraclip procedure. There was no device malfunction. No additional information was provided regarding this issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024168-2020-02715 |
| MDR Report Key | 9860916 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-20 |
| Date of Report | 2020-03-20 |
| Date of Event | 2018-11-09 |
| Date Mfgr Received | 2020-02-26 |
| Device Manufacturer Date | 2018-07-23 |
| 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 |
| Catalog Number | SGC0302 |
| Lot Number | 80723U124 |
| Device Expiration Date | 2019-07-23 |
| 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 | 2020-03-20 |