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 2020-02-17 for RASHKIND CATHETER 008764 manufactured by Medtronic, Inc.
[182921639]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[182921640]
A rashkind septostomy balloon catheter was used during a procedure to treat the septum. There was no damage noted to the packaging, the device was removed from packaging per ifu. The device was inspected with no issues. The device was prepped per ifu with no issues. Resistance was not encountered when advancing the device. Excessive force was not used during insertion. It was reported that the balloon burst during inflation. The patient is alive with no injury.
Patient Sequence No: 1, Text Type: D, B5
[188506504]
The balloon burst at 2cc. The device was being used in one action from the left atrium to right atrium. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1220452-2020-00021 |
| MDR Report Key | 9716274 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-17 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-02-12 |
| Date Mfgr Received | 2020-03-02 |
| Device Manufacturer Date | 2019-05-28 |
| Date Added to Maude | 2020-02-17 |
| 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 | TONI O'DOHERTY |
| Manufacturer Street | PARKMORE BUSINESS PARK WEST |
| Manufacturer City | GALWAY |
| Manufacturer Phone | 091708734 |
| Manufacturer G1 | MEDTRONIC, INC |
| Manufacturer Street | 37A CHERRY HILL DR |
| Manufacturer City | DANVERS MA 01923 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01923 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RASHKIND CATHETER |
| Generic Name | CATHETER, SEPTOSTOMY |
| Product Code | DXF |
| Date Received | 2020-02-17 |
| Catalog Number | 008764 |
| Lot Number | GFDN3554 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC, INC |
| Manufacturer Address | 37A CHERRY HILL DR DANVERS MA 01923 US 01923 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-17 |