MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-24 for ARMADA 14 PTA CATHETER A2020-120 manufactured by Abbott Vascular.
[184738380]
Event estimated date. The device is expected to be returned for investigation. It has not yet been received. A follow-up report will be submitted with all additional relevant information.
Patient Sequence No: 1, Text Type: N, H10
[184738381]
It was reported that an armada 14 balloon dilatation catheter (bdc) was faulty. The bdc was unable to use/inflate as liquid was leaking out at distal end near black connection. The method used to complete the procedure was not provided. There was no clinically significant delay in the procedure and no adverse patient sequela. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024168-2020-02810 |
| MDR Report Key | 9874072 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-24 |
| Date of Report | 2020-03-24 |
| Date of Event | 2020-02-27 |
| Date Mfgr Received | 2020-02-28 |
| Device Manufacturer Date | 2019-09-09 |
| Date Added to Maude | 2020-03-24 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 2020-03-24 |
| Model Number | A2020-120 |
| Catalog Number | A2020-120 |
| Lot Number | 9090941 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2020-03-24 |