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 2020-02-26 for CXI SUPPORT CATHETER G23862 CXI-2.6-18-65-ANG2 manufactured by Cook Inc.
[181959319]
Customer name and address= phone: (b)(6). Occupation = unknown. Pma/510(k) number = k122796. 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
[181959320]
As reported, during an unknown procedure involving the knee region, the tip of a cxi support catheter separated. The tip "hooked" and buckled on the way down the superficial femoral artery. The user pulled back the catheter in an attempt to straighten the device, at which time the user felt the catheter hook on the unknown sheath. The user reportedly straightened the device, pulled back the sheath, and reinserted the catheter. The catheter had not been pulled completely out of the patient. Imaging was performed and the user noted that the shape of the device tip was different. The catheter was removed and the tip was found to be separated. The separated device tip was then discovered outside of the patient's body, having been pulled out with the sheath. Another device from the same lot was used to complete the procedure. There was no adverse outcome.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2020-00477 |
| MDR Report Key | 9759052 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-26 |
| Date of Report | 2020-02-26 |
| Date of Event | 2020-02-14 |
| Date Mfgr Received | 2020-02-14 |
| Device Manufacturer Date | 2019-07-09 |
| Date Added to Maude | 2020-02-26 |
| 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 | CXI SUPPORT CATHETER |
| Generic Name | KRA CATHETER, CONTINUOUS FLUSH |
| Product Code | KRA |
| Date Received | 2020-02-26 |
| Model Number | G23862 |
| Catalog Number | CXI-2.6-18-65-ANG2 |
| Lot Number | 9866808 |
| 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 | 2020-02-26 |