MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2019-04-01 for AMPLATZER? DUCT OCCLUDER (UNKNOWN) CVD0093 manufactured by Aga Medical Corporation.
[140533774]
An event of premature deployment and embolism 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 was due to an admitted operator error. According to the instructions for use, artmt 600034251 version b, "when correct placement is confirmed, release the occluder".
Patient Sequence No: 1, Text Type: N, H10
[140533775]
The following information is from a publication. On an unknown date, a amplatzer duct occluder (ado) was selected for percutaneous transcatheter closure of the patent ductus in a (b)(6) female. During deployment, the device disconnected from the connector due to operator error. The device embolized to the pulmonary artery and percutaneous retrieval was attempted. A 6f judkins right coronary catheter was advanced into the pulmonary artery with a guidewire. The device had become stuck in the branch of the right pulmonary artery and was unable to be retrieved with an amplatz gooseneck snare. A bioptome was introduced from the left femoral vein through a 7f sheath. After multiple attempts, the device was successfully captured and removed. A new ado was implanted in the same procedure and no patient consequences were reported. No additional information will be provided (doi: 10. 1177/1538574418823384).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2135147-2019-00093 |
| MDR Report Key | 8470763 |
| Report Source | FOREIGN |
| Date Received | 2019-04-01 |
| Date of Report | 2019-04-01 |
| Date Mfgr Received | 2019-03-07 |
| Date Added to Maude | 2019-04-01 |
| 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 (UNKNOWN) |
| Generic Name | AMPLATZER? DUCT OCCLUDER |
| Product Code | MAE |
| Date Received | 2019-04-01 |
| Model Number | CVD0093 |
| 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 | 2019-04-01 |