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 2020-02-25 for AMPLATZER SIZING BALLOON II 9-SB-018 manufactured by Aga Medical Corporation.
[181825541]
An event of hemodynamic compromise and reduced right ventricle compression after the sizing balloon was decompressed was reported. The results of the investigation are inconclusive since the device was not returned for analysis. The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications. Based on the information received, the cause of the reported incident could not be conclusively determined. Please note, per the instruction for use, artmt100092312 revision a " this device was sterilized with ethylene oxide and is for single use only. Do not reuse or resterilize this device. "
Patient Sequence No: 1, Text Type: N, H10
[181825542]
On (b)(6) 2020, a 12/10mm amplatzer duct occluder was selected for implant using a 7f amplatzer torqvue delivery system (ds) to close a fistula, aware this is an off-label use. However, the occluder was not released because it did not remain seated when tugged. The device was removed from the patient and the physician decided to re-measure the fistula with an 18mm amplatzer sizing balloon. The fistula measured about 14mm and the sizing balloon was decompressed. However, the patient became severely hemodynamically compromised and had reduced right ventricle compression. The sizing balloon was re-inserted and re-inflated to block the shunt and the patient regained hemodynamic stability. A 16mm amplatzer muscular vsd occluder was selected for implant using a 9f amplatzer torqvue ds to close the fistula; the physician is aware this is off-label use. There was significant resistance when inserting the delivery sheath. The 16mm occluder was successfully implanted. The patient was hemodynamically stable at the end of the procedure and moved to the ccu for observation. The patient is reportedly stable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2135147-2020-00046 |
| MDR Report Key | 9751489 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-25 |
| Date of Report | 2020-02-25 |
| Date of Event | 2020-01-27 |
| Date Mfgr Received | 2020-01-27 |
| Device Manufacturer Date | 2019-03-27 |
| Date Added to Maude | 2020-02-25 |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AMPLATZER SIZING BALLOON II |
| Generic Name | CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY |
| Product Code | MJN |
| Date Received | 2020-02-25 |
| Model Number | 9-SB-018 |
| Catalog Number | 9-SB-018 |
| Lot Number | 6922464 |
| 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 | 2020-02-25 |