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 2019-02-26 for AMPLATZER DUCT OCCLUDER 9-PDA-006 manufactured by Aga Medical Corporation.
[137118257]
On (b)(6) 2019, 5mm amplatzer duct occluder was selected for use and positioned at the patient's defect, but deemed unsuitable due to size, so the device was re-sheathed and removed. A 6mm amplatzer duct occluder was then selected for implant. After the 6mm device was re-positioned three times, on the third attempt, the device released from the cable prematurely and embolized. The device was snared via the femoral artery and the patient is reported to be discharged. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2135147-2019-00048 |
| MDR Report Key | 8369565 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-02-26 |
| Date of Report | 2019-04-12 |
| Date Mfgr Received | 2019-04-05 |
| Device Manufacturer Date | 2018-03-26 |
| Date Added to Maude | 2019-02-26 |
| 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 | 2019-02-26 |
| Model Number | 9-PDA-006 |
| Catalog Number | 9-PDA-006 |
| Lot Number | 6379627 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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. Required No Informationntervention | 2019-02-26 |