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 2020-03-27 for HT COMMAND 18 1013731 manufactured by Abbott Vascular.
[188554175]
The device was received. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information.
Patient Sequence No: 1, Text Type: N, H10
[188554176]
It was reported that this was a percutaneous procedure attempting to treat a 100% occluded anterior tibial artery. The command 18 st guide wire was advanced with a non-abbott support catheter when the guide wire became lodged in the anterior tibial artery. During the attempt to remove the guide wire, approximately one cm of the wire separated in the vessel. Attempts were made to snare out the separated segment, but were not successful. There is no concern for embolization as the guide wire is in a chronically occluded vessel. The procedure was aborted and the patient remained stable throughout. There was no additional information provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024168-2020-03015 |
| MDR Report Key | 9889037 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-27 |
| Date of Event | 2020-03-11 |
| Date Mfgr Received | 2020-03-11 |
| Device Manufacturer Date | 2019-07-16 |
| Date Added to Maude | 2020-03-27 |
| 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 # 2024168 |
| Manufacturer Street | 26531 YNEZ ROAD |
| Manufacturer City | TEMECULA CA 925914628 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 925914628 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HT COMMAND 18 |
| Generic Name | GUIDE WIRE |
| Product Code | DQX |
| Date Received | 2020-03-27 |
| Returned To Mfg | 2020-03-25 |
| Model Number | 1013731 |
| Catalog Number | 1013731 |
| Lot Number | 9071661 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| 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 | 2020-03-27 |