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 ARMADA 14 PTA CATHETER A2020-080 manufactured by Abbott Vascular.
[184902106]
The customer reported the device was discarded. Investigation is not yet complete. A follow-up will be submitted with all relevant information. The ht command es guide wire referenced is filed under a separate medwatch report number.
Patient Sequence No: 1, Text Type: N, H10
[184902107]
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 | 2024168-2020-02866 |
| MDR Report Key | 9878950 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-25 |
| Date of Event | 2020-03-03 |
| Date Mfgr Received | 2020-03-03 |
| Device Manufacturer Date | 2019-04-11 |
| 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 # 3005718570 (P099) |
| Manufacturer Street | CASHEL ROAD |
| Manufacturer City | CLONMEL TIPPERARY |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARMADA 14 PTA CATHETER |
| Generic Name | PERIPHERAL DILATATION CATHETER |
| Product Code | DQY |
| Date Received | 2020-03-25 |
| Model Number | A2020-080 |
| Catalog Number | A2020-080 |
| Lot Number | 9041141 |
| 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 |