MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2020-03-05 for ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE G56174 HPWA-35-180 manufactured by Cook Inc.
[183531518]
The used devices will not be returned. Common name & product code = dqx wire, guide, catheter. Concomitant products= boston scientific gladiator balloon (8x8); fogarty (edwards scientific); latex sensi touch gloves. Occupation = lead tech. This report includes information known at this time. A follow-up report will be submitted should additional relevant information become available.
Patient Sequence No: 1, Text Type: N, H10
[183531519]
As reported, during an unknown procedure, the coating of two roadrunner uniglide hydrophilic wire guides would not activate appropriately, became sticky, and came off the wire. The hydrophilic coating was activated with saline, and the device remained in saline when not in use throughout the procedure. Latex gloves were worn. Access was obtained in the left upper arm. The anatomy was not reported to be calcified or tortuous. The wire was not altered prior to use and kinking was not observed. Flaking of the coating was observed. The flakes were clear but reportedly appeared white while on the wire. The procedure was completed with another device. Patient care was not impacted, and no portion of the device or coating was left in the patient. A section of the device did not remain inside the patient? S body. The patient did not require any additional procedures due to this occurrence. According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2020-00554 |
| MDR Report Key | 9793170 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2020-03-05 |
| Date of Report | 2020-03-05 |
| Date Mfgr Received | 2020-02-28 |
| Device Manufacturer Date | 2019-10-03 |
| Date Added to Maude | 2020-03-05 |
| 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 UNIGLIDE HYDROPHILIC WIRE GUIDE |
| Generic Name | DQX WIRE, GUIDE, CATHETER |
| Product Code | DXQ |
| Date Received | 2020-03-05 |
| Model Number | G56174 |
| Catalog Number | HPWA-35-180 |
| Lot Number | 10049863 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2020-03-05 |