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.
[183258630]
The device was not returned. A review of the lot history record revealed no manufacturing issued to the reported lot. Additionally, a review of the complaint history identified no other incidents reported from this lot. All available information was investigated, a definitive cause for the reported leak could not be determined. There is no indication of a product quality issue with respect to manufacture, design or labeling.
Patient Sequence No: 1, Text Type: N, H10
[183258631]
This report is being filed due to an air leak during device preparation. It was reported that during steerable guide catheter (sgc) preparation per ifu, each time the dilator was inserted and advanced, air was observed in the sgc chamber. The sgc would pass the air column tests, there was no unusual resistance inserting or advancing the dilator, and no source of leak could be found, however, each time the dilator advanced, air was observed in the sgc chamber. The stopcocks were changed out with the same issue noted. The device was not used in the anatomy and there was no patient involvement. No additional information was provided regarding this device issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024168-2020-02376 |
| MDR Report Key | 9826403 |
| 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 | 2019-12-14 |
| 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 | 91213U205 |
| 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 | 2020-03-12 |