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 2019-01-22 for RASHKIND CATHETER 008764 manufactured by Medtronic, Inc.
[133753213]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[133753214]
A rashkind septostomy balloon catheter was intended to be used to treat a patient with a transposition of vessels and to open a shunt. There was no damage noted to packaging and there were no issues removing the device form the hoop/tray. The device was inspected with no issues noted. Negative prep was performed with no issues. The lesion was not pre-dilated. The device did not pass through a previously deployed stent. There was no resistance encountered when advancing the device and excessive force was not used during delivery. It is reported that on the second inflation of the device, the balloon burst. No patient injury is reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220452-2019-00008 |
| MDR Report Key | 8266843 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-01-22 |
| Date of Report | 2019-02-25 |
| Date of Event | 2019-01-11 |
| Date Mfgr Received | 2019-01-29 |
| Device Manufacturer Date | 2017-03-28 |
| Date Added to Maude | 2019-01-22 |
| 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 | 2019-01-22 |
| Returned To Mfg | 2019-02-19 |
| Catalog Number | 008764 |
| Lot Number | GFAY2422 |
| Device Expiration Date | 2019-03-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2019-01-22 |