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 2019-03-08 for AMPLATZER DUCT OCCLUDER 9-PDA-005 manufactured by Aga Medical Corporation.
[138273061]
On (b)(6) 2019, a 8/6mm amplatzer duct occluder (pda) was selected for implant. During device preparation, the pda was observed to be in an irregular shape and the nitinol wires were separated. The device was deemed appropriate for use and inserted into the patient. Upon deployment, blood was flowing through the shunt. The device was re-sheathed and replaced with a 10/8mm pda. The procedure was successfully completed and the patient remained hemodynamically stable throughout.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2135147-2019-00070 |
| MDR Report Key | 8404518 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-03-08 |
| Date of Report | 2019-07-26 |
| Date of Event | 2019-02-10 |
| Date Mfgr Received | 2019-07-14 |
| Device Manufacturer Date | 2018-04-20 |
| Date Added to Maude | 2019-03-08 |
| 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 | 2019-03-08 |
| Model Number | 9-PDA-005 |
| Catalog Number | 9-PDA-005 |
| Lot Number | 6418284 |
| 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. Required No Informationntervention | 2019-03-08 |