MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2020-03-04 for RENEGADE HI-FLO KIT 29460 manufactured by Boston Scientific Corporation.
[182200936]
Age at time of event: reported as (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[182200937]
It was reported that proximal part of the device was separated from its shaft. A 135/20 renegade hi-flo kit was selected for use in the prostate. During preparation for the procedure, after the device was flushed and pulled out smoothly and slowly from inside the sheath, the proximal part was noted to be separated from it's shaft. The device was removed. The procedure was completed with another of the same device. No patient complications reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-02461 |
| MDR Report Key | 9788020 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-03-04 |
| Date of Report | 2020-03-12 |
| Date of Event | 2020-02-12 |
| Date Mfgr Received | 2020-03-10 |
| Device Manufacturer Date | 2019-02-06 |
| Date Added to Maude | 2020-03-04 |
| 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 | JAY JOHNSON |
| Manufacturer Street | TWO SCIMED PLACE |
| Manufacturer City | MAPLE GROVE MN 55311 |
| Manufacturer Country | US |
| Manufacturer Postal | 55311 |
| Manufacturer Phone | 7634942574 |
| Manufacturer G1 | BOSTON SCIENTIFIC CORK LIMITED |
| Manufacturer Street | MODEL FARM ROAD |
| Manufacturer City | CORK |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RENEGADE HI-FLO KIT |
| Generic Name | CATHETER, CONTINUOUS FLUSH |
| Product Code | KRA |
| Date Received | 2020-03-04 |
| Returned To Mfg | 2020-03-05 |
| Model Number | 29460 |
| Catalog Number | 29460 |
| Lot Number | 0023302343 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Address | TWO SCIMED PLACE MAPLE GROVE MN 55311 US 55311 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-04 |