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 2019-05-24 for AMPLATZER DUCT OCCLUDER 9-PDA-005 manufactured by Aga Medical Corporation.
[146096219]
Further information regarding this event has been requested.
Patient Sequence No: 1, Text Type: N, H10
[146096220]
On (b)(6) 2019, an 8mm amplatzer amulet was selected for implant. The device was reported to have "slipped through. " the physician elected to exchange the device for a 8/6mm amplatzer duct occluder and the device embolized to the aorta and was removed from the patient. A 6/4mm amplatzer duct occluder was successfully implanted and the procedure was completed with no patient consequences.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2135147-2019-00126 |
| MDR Report Key | 8641395 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-05-24 |
| Date of Report | 2019-07-31 |
| Date of Event | 2019-04-26 |
| Date Mfgr Received | 2019-07-23 |
| Device Manufacturer Date | 2015-08-29 |
| Date Added to Maude | 2019-05-24 |
| 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 | 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 | 2019-05-24 |
| Returned To Mfg | 2019-07-16 |
| Model Number | 9-PDA-005 |
| Catalog Number | 9-PDA-005 |
| Lot Number | 5212513 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2019-05-24 |