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 2020-03-26 for HT COMMAND 14 2078175 manufactured by Abbott Vascular.
[185093309]
The product was not returned to abbott for analysis. Return of the guide wire may have further aided the analysis. The investigation was unable to determine a conclusive cause for the reported difficulty to advance or difficulty to remove. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event. Additionally, a review of the complaint history identified no other incidents and/or complaint reported from this lot. There was no damage noted to the guide wire during the inspection prior to preparation of the wire which suggests a product quality issue did not contribute to the reported difficulties. 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
[185093310]
It was reported that this was a procedure to treat the posterior tibial artery. During advancement the command guide wire became stuck inside a non-abbott crossing catheter. The command guide wire could not be removed from the crossing catheter, so both devices were removed as a unit. The procedure was aborted. There were no adverse patient effects and no clinically significant delay in the procedure. There was no additional information provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024168-2020-02958 |
| MDR Report Key | 9884425 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-26 |
| Date of Event | 2020-03-03 |
| Date Mfgr Received | 2020-03-06 |
| Device Manufacturer Date | 2019-12-09 |
| Date Added to Maude | 2020-03-26 |
| 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 | 2020-03-26 |
| Model Number | 2078175 |
| Catalog Number | 2078175 |
| Lot Number | 9120971 |
| 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 | 2020-03-26 |