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.
[184902331]
A visual inspection was performed on the returned guide wire, and 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 balloon catheter used during the procedure became damaged as it was used multiple times, causing the difficulty to remove; however, this could not be confirmed. There is no indication of a product quality issue with respect to manufacture, design or labeling. The armada 14 device referenced is filed under a separate medwatch report number.
Patient Sequence No: 1, Text Type: N, H10
[184902332]
It was reported that the procedure was performed to treat a lesion in the right anterior tibial artery. A ht command es guide wire was advanced to the lesion and a 2. 0x80mm armada 14 balloon catheter was advanced over the guide wire without issues. The balloon catheter was removed and an attempt to advance an unspecified 014 laser catheter over the guide wire was made; however, resistance was felt. The guide wire was removed, and a non-abbott guide wire was advanced. The laser catheter was advanced over the non-abbott guide wire without issues and the lesion was lasered. The laser catheter was removed, and the same armada 14 balloon catheter was advanced on the non-abbott guide wire. The non-abbott guide wire was removed, and the balloon catheter was used as an exchange catheter. A new ht command es guide wire was advanced through the balloon catheter and the lesion was dilated. During removal of the guide wire, resistance was felt with the balloon catheter and both were removed as a unit. 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 | 2024168-2020-02864 |
| MDR Report Key | 9878887 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-30 |
| 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 | 2020-03-09 |
| 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 |