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 2019-10-04 for HIWIRE HYDROPHILIC WIRE GUIDE G36282 HWA-35-150 manufactured by Cook Inc.
[164625684]
Common name & product code: dqx wire, guide, catheter. Occupation: interventional radiology supervisor. A follow-up report will be submitted should additional relevant information become available.
Patient Sequence No: 1, Text Type: N, H10
[164625685]
It was reported, during a procedure involving gastrostomy-jejunostomy (gj) tube change / placement, the hiwire hydrophilic wire guide used during the procedure had exposed burrs on the surface with very rough edges. The wire was used without incident. Details related to the procedure such as the access site and patient anatomy are unknown. There were no kinks present, but there was concern that the burrs may have been sharp. 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 | 1820334-2019-02538 |
| MDR Report Key | 9156733 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2019-10-04 |
| Date of Report | 2019-10-04 |
| Date Mfgr Received | 2019-09-30 |
| Device Manufacturer Date | 2019-04-02 |
| Date Added to Maude | 2019-10-04 |
| 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 | MR. LARRY POOL |
| 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 | HIWIRE HYDROPHILIC WIRE GUIDE |
| Generic Name | DQX WIRE, GUIDE, CATHETER |
| Product Code | DXQ |
| Date Received | 2019-10-04 |
| Model Number | G36282 |
| Catalog Number | HWA-35-150 |
| Lot Number | 11136991 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2019-10-04 |