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 2018-11-14 for AMPLATZER DUCT OCCLUDER 9-PDA-004 manufactured by Aga Medical Corporation.
[127204421]
An event of deformity was reported. The results of the investigation are inconclusive since the device was not returned for analysis. The device history record was reviewed to ensure that each manufacturing and inspection operation was performed. Based on the information received, the cause of the reported incident could not be conclusively determined.
Patient Sequence No: 1, Text Type: N, H10
[127204422]
On (b)(6) 2018, a 6/4 mm amplatzer duct occluder (ado) was selected for use. The 6/4mm ado device was deployed, but the retention skirt was deformed in a round shape. The physician waited to see if the deformity would correct, but it did not correct itself. The 6/4mm ado device was safely removed and a second 6/4mm ado was successfully deployed with no further issues. The patient remained hemodynamically stable through the procedure and there were no adverse patient consequences. The procedure was not significantly extended. Per md report, the deformation was unlikely to result in a patient harm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2135147-2018-00215 |
| MDR Report Key | 8072388 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-11-14 |
| Date of Report | 2018-11-14 |
| Date of Event | 2018-10-25 |
| Date Mfgr Received | 2018-10-25 |
| Device Manufacturer Date | 2018-09-11 |
| Date Added to Maude | 2018-11-14 |
| 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 | STEPHANIE O' SULLIVAN |
| Manufacturer Street | 5050 NATHAN LANE NORTH |
| Manufacturer City | PLYMOUTH MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal | 55442 |
| Manufacturer Phone | 6517565400 |
| Manufacturer G1 | AGA MEDICAL CORPORATION |
| Manufacturer Street | 5050 NATHAN LANE NORTH |
| Manufacturer City | PLYMOUTH MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55442 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AMPLATZER DUCT OCCLUDER |
| Generic Name | OCCLUDER, PATENT DUCTUS, ARTERIOSUS |
| Product Code | MAE |
| Date Received | 2018-11-14 |
| Model Number | 9-PDA-004 |
| Catalog Number | 9-PDA-004 |
| Lot Number | 6630737 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AGA MEDICAL CORPORATION |
| Manufacturer Address | 5050 NATHAN LANE NORTH PLYMOUTH MN 55442 US 55442 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2018-11-14 |