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 2020-01-08 for RASHKIND CATHETER 008764 manufactured by Medtronic, Inc.
[182918647]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[182918648]
A 6f 50cm wvn rashkind rec bal was used during a procedure to treat a lesion. There was no damage noted to the packaging. The device was removed from packaging per ifu with no issues. The device was inspected with no issues. The device was prepped per ifu with no issue. It was reported that the balloon burst at 1. 5cc. The patient is alive with no injury.
Patient Sequence No: 1, Text Type: D, B5
[188524854]
Product analysis #(b)(4): one rashkind device was returned for analysis. The curve retainer was also returned. As received, the balloon had pulled over the distal end. The inflation hole was visible. The balloon was pulled back and no damage was noted to the tip. It appears the balloon had pulled out from underneath the proximal balloon tie. Vendor analysis the balloon could not be inflated for testing as the proximal end was pulled out from the balloon tie and pulled out and over the top of the distal end. 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 was 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
| Report Number | 1220452-2020-00003 |
| MDR Report Key | 9564020 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-08 |
| Date of Report | 2020-03-25 |
| Date of Event | 2019-12-27 |
| Date Mfgr Received | 2020-03-18 |
| Device Manufacturer Date | 2019-01-28 |
| Date Added to Maude | 2020-01-08 |
| 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 | 2020-01-08 |
| Returned To Mfg | 2020-02-19 |
| Catalog Number | 008764 |
| Lot Number | GFCX2712 |
| 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 | 2020-01-08 |