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 2020-03-25 for HT COMMAND 14 2078175 manufactured by Abbott Vascular.
[185001644]
Event estimated date. The incident information was reviewed; however, the product was not returned to abbott vascular for analysis. A review of the electronic lot history record, corrective action tracking system for the web database review and similar incident query for this product was not performed since the lot number was not reported. There was no damage noted to the guide wire during the inspection prior to use which suggests a product quality issue with respect to manufacture, design or labeling did not contribute to the reported difficulties. Based on the limited information provided, the investigation was unable to determine a conclusive cause for the reported difficulty to advance and difficulty to remove. In this case, it is possible that the laser device used caused damage to the polymer coating causing the reported difficulties however; this could not be confirmed. There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Patient Sequence No: 1, Text Type: N, H10
[185001645]
This is being reported as a general comment indicating that resistance during advancement and removal is felt when using the ht command es guide wire with an unspecified 014 laser catheter. There were no adverse patient effects and no clinically significant delay in the procedure. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024168-2020-02911 |
| MDR Report Key | 9881564 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-25 |
| Date of Event | 2020-03-02 |
| Date Mfgr Received | 2020-03-03 |
| Date Added to Maude | 2020-03-25 |
| 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 # 3005737652 |
| Manufacturer Street | ROAD NO.2 KM 58.0 CRUCE D |
| Manufacturer City | BARCELONETA PR 00617 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 00617 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HT COMMAND 14 |
| Generic Name | GUIDE WIRE |
| Product Code | DQX |
| Date Received | 2020-03-25 |
| Model Number | 2078175 |
| Catalog Number | 2078175 |
| 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 | 2020-03-25 |