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 2020-01-15 for RASHKIND CATHETER 008764 manufactured by Medtronic, Inc.
[182919010]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[182919011]
During a procedure two 6f rashkind catheters were used to treat the septum. There was no damage noted to the packaging. The device removed from packaging per ifu with no issues. 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. It was reported that there was a device detachment. It was reported that there was a rupture of the balloon portion. The patient is alive with no injury.
Patient Sequence No: 1, Text Type: D, B5
[188530907]
Product analysis (b)(4): one rashkind device was returned for analysis. As received, the balloon was detached from the proximal balloon tie as the balloon had pulled out from underneath the proximal balloon tie. No damage was noted to the distal balloon seal or tip. Vendor analysis the balloon could not be inflated for testing as the proximal end was pulled out from the balloon tie. Approx. A 2mm section of the material over the area of the balloon tie was sliced open and removed. There were no remnants of the latex balloon present in the area of the proximal balloon tie. The glue ridge was present, and there was no apparent damage. There is no visible evidence of a tear or breakage of the latex balloon. The balloon appears to have been pulled out from underneath the proximal balloon tie. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[188530908]
During a procedure two 6f rashkind catheters were used to treat the septum. There was no damage noted to the packaging. The devices were removed from packaging per ifu with no issues. The devices were inspected with no issues. The devices were prepped per ifu with no issues. Resistance was not encountered when advancing the devices. Excessive force was not used. It was reported that there was a detachment of balloon material. It was reported that there was a rupture of the balloon portion. The rupture occurred during inflation. The detached portion was removed from the vessel as usual. The patient is alive with no injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220452-2020-00006 |
| MDR Report Key | 9590976 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-15 |
| Date of Report | 2020-04-01 |
| Date Mfgr Received | 2020-03-19 |
| Device Manufacturer Date | 2019-03-28 |
| Date Added to Maude | 2020-01-15 |
| 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 | 2020-01-15 |
| Returned To Mfg | 2020-01-10 |
| Catalog Number | 008764 |
| Lot Number | GFCY2997 |
| 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 | 2020-01-15 |