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 2020-03-27 for AMPLATZER CRIBRIFORM OCCLUDER 9-ASD-MF-025 manufactured by Aga Medical Corporation.
[185324754]
Further information regarding this event has been requested. The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
Patient Sequence No: 1, Text Type: N, H10
[185324755]
On (b)(6) 2020, a 25mm amplatzer cribriform occluder (lot#7262218) was selected for implant. The device was prepared in the normal procedure. Once inside the patient, distortion was seen on the disc when opened on the left atrium side. The same deformity was seen on the disc when opened on the right atrium side. Another 25mm amplatzer cribriform occluder (lot#7253343) was selected for implant, but the same deformation was seen during preparation. The device did not come in contact with the patient. A 25mm amplatzer pfo occluder was then selected for implant and the process was completed successfully. The patient remained stable throughout the procedure and there was no clinically significant delay in the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2135147-2020-00098 |
| MDR Report Key | 9891567 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-27 |
| Date of Event | 2019-02-28 |
| Date Mfgr Received | 2020-02-28 |
| Device Manufacturer Date | 2019-11-07 |
| Date Added to Maude | 2020-03-27 |
| 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 | PAMELA YIP |
| Manufacturer Street | 5050 NATHAN LANE N |
| 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 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AMPLATZER CRIBRIFORM OCCLUDER |
| Generic Name | TRANSCATHETER SEPTAL OCCLUDER |
| Product Code | MLV |
| Date Received | 2020-03-27 |
| Model Number | 9-ASD-MF-025 |
| Catalog Number | 9-ASD-MF-025 |
| Lot Number | 7262218 |
| 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 | 2020-03-27 |