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 2018-12-18 for AMPLATZER DUCT OCCLUDER 9-PDA-003 manufactured by Aga Medical Corporation.
[130626983]
An event of embolization was reported. The results of the investigation are inconclusive since the device was not returned for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. Information from the field indicated that " a larger amplatzer duct occluder was used to close the pda. "
Patient Sequence No: 1, Text Type: N, H10
[130626984]
On (b)(6) 2018, a 5/4mm amplatzer duct occluder was implanted. Three hours after the procedure was completed and the patient was recovering in the nicu, the device embolized to the descending aorta. A 5f bioptome was used to grab the pa side pin (end screw) and the device was smoothly resheathed and removed. A larger amplatzer duct occluder was used to close the pda. There were no patient consequences reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2135147-2018-00241 |
| MDR Report Key | 8173386 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-12-18 |
| Date of Report | 2018-12-18 |
| Date of Event | 2018-11-02 |
| Date Mfgr Received | 2018-11-20 |
| Device Manufacturer Date | 2018-09-12 |
| Date Added to Maude | 2018-12-18 |
| 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 | 2018-12-18 |
| Model Number | 9-PDA-003 |
| Catalog Number | 9-PDA-003 |
| Lot Number | 6631855 |
| 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 | 2018-12-18 |