MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,other,use report with the FDA on 2020-02-28 for ROADRUNNER NIMBLE HYDROPHILIC WIRE GUIDE G17542 RFSPC-035145-0 manufactured by Cook Inc.
[181954088]
Occupation: other non-healthcare professional: analyst. The event is currently under investigation. A follow-up report will be submitted upon receipt of additional information or completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[181954089]
It was reported on 23jan2020 that prior to a ureterolithotrisy and double j stent implant, a roadrunner nimble hydrophilic wire guide could not be removed from the protective sheath and did not make patient contact. Another wire guide was used to complete the procedure. Upon return of the device from the customer for investigation, 26feb2020, it was discovered that the wire guide had broken or separated within the holder. It was reported that the patient did not experience any adverse effects due to this occurrence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2020-00492 |
| MDR Report Key | 9768603 |
| Report Source | DISTRIBUTOR,FOREIGN,OTHER,USE |
| Date Received | 2020-02-28 |
| Date of Report | 2020-02-28 |
| Date of Event | 2019-09-22 |
| Date Mfgr Received | 2020-01-23 |
| Device Manufacturer Date | 2019-01-16 |
| Date Added to Maude | 2020-02-28 |
| 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 | MRS. JENNIFER CANADA |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8123392235 |
| Manufacturer G1 | COOK INC |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 47404 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ROADRUNNER NIMBLE HYDROPHILIC WIRE GUIDE |
| Generic Name | OCY ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY |
| Product Code | OCY |
| Date Received | 2020-02-28 |
| Returned To Mfg | 2020-02-26 |
| Model Number | G17542 |
| Catalog Number | RFSPC-035145-0 |
| Lot Number | 9450440 |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK INC |
| Manufacturer Address | 750 DANIELS WAY BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-28 |