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 ES 14 2078175 manufactured by Abbott Vascular.
[185000119]
A visual and dimensional inspection was performed on the returned guide wire; however, the reported difficulty to remove could not be confirmed. Possible factors that may contribute to difficulty to remove the guide wire from the delivery device can be affected by numerous factors including, but not limited to, manufacturing, guide wire damages, damage on the shaft of the catheter, outer diameter of the guide wire, inner diameter of the guide wire lumen or procedural contaminates. Design and manufacturing controls have been established to mitigate possible causes. 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 did not indicate a lot specific quality issue. The investigation was unable to determine a conclusive cause for the reported difficulty to remove. Based on the reported information it is possible that the technique used to remove the non-abbott ivus catheter, caused the reported resistance to be felt with the guide wire; however, this could not be confirmed. There is no indication of a product quality issue with respect to manufacture, design or labeling. The additional ht command es guide wire referenced is filed under a separate medwatch report number.
Patient Sequence No: 1, Text Type: N, H10
[185000120]
It was reported that the procedure was performed to treat a chronic totally occluded lesion in the tibioperoneal trunk, peroneal artery, and superficial femoral artery. A ht command es guide wire was advanced and an intravascular ultrasound (ivus) catheter was advanced over the guide wire. An attempt to remove the ivus catheter was made; however, resistance with the guide wire was felt. Both were removed as a unit. A new ht command guide wire was advanced, and an unspecified laser catheter was advanced over the guide wire. An attempt to remove the laser catheter was made; however, resistance with the guide wire was felt, but the laser catheter was able to be removed. The guide wire was removed, and the procedure was successfully completed. 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 | 2024168-2020-02910 |
| MDR Report Key | 9881536 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-27 |
| Date of Event | 2020-03-03 |
| Date Mfgr Received | 2020-03-26 |
| Device Manufacturer Date | 2019-09-03 |
| 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 ES 14 |
| Generic Name | GUIDE WIRE |
| Product Code | DQX |
| Date Received | 2020-03-25 |
| Returned To Mfg | 2020-03-10 |
| Model Number | 2078175 |
| Catalog Number | 2078175 |
| Lot Number | 9090371 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 |