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 2020-03-24 for ARMADA 18 PTA CATHETER 1013470-150 manufactured by Abbott Vascular.
[184844325]
The device was not returned for analysis. It may be possible that the balloon interacted with anatomy or associated devices causing damage to the outer surface and resulting in balloon rupture; however, this could not be determined. A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint. Additionally, a review of the complaint history did not indicate a lot specific quality issue. The investigation was unable to determine a cause for the reported balloon rupture. There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device. The additional armada device referenced is being filed under a separate medwatch report.
Patient Sequence No: 1, Text Type: N, H10
[184844326]
It was reported that the procedure was performed to treat a calcified lesion in the mid superficial femoral artery. Two 6x150mm armada 18 balloons ruptured during the first inflation at 8 atmospheres. The procedure was successfully completed with arthrectomy and an additional unspecified balloon catheter. 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 | 2024168-2020-02842 |
| MDR Report Key | 9876034 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-24 |
| Date of Report | 2020-03-24 |
| Date of Event | 2020-03-02 |
| Date Mfgr Received | 2020-03-02 |
| Device Manufacturer Date | 2019-09-25 |
| 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 |
| 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 18 PTA CATHETER |
| Generic Name | PERIPHERAL DILATATION CATHETER |
| Product Code | LIT |
| Date Received | 2020-03-24 |
| Model Number | 1013470-150 |
| Catalog Number | 1013470-150 |
| Lot Number | 9092541 |
| 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 | 2020-03-24 |