MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-12 for CXI SUPPORT CATHETER CXI-4.0-35-90-P-NS-DAV manufactured by Cook Inc.
[188631905]
Concomitant medical products: additional devices used includes a micropuncture to gain access and likely other catheters which were unspecified. Occupation: lab manager. Pma/510(k): k160884. (b)(4). 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
[188631906]
It was reported that the tip of a cxi support catheter separated from the shaft during a procedure and had to be removed from the patient. The access site for the wire was the femoral artery, but the target location remains unknown. While trying to cross an occlusion, there was a "heavy amount of torquing and twisting". The first catheter that was used separated at the hub, reported in mdr: 1820334-2020-00598. A second catheter was used to complete the procedure. During use of this catheter, it was reported "there was some torquing", and subsequently the tip of the catheter separated from the shaft. A snare was used to successfully remove the tip of the catheter from the patient. A micropuncture was used to gain access, and other catheters were also used during the procedure. It is unknown if the patient's anatomy was tortuous or calcified. It was reported there were no adverse effects to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2020-00599 |
| MDR Report Key | 9823858 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-12 |
| Date of Report | 2020-03-12 |
| Date of Event | 2020-02-11 |
| Date Mfgr Received | 2020-02-27 |
| Date Added to Maude | 2020-03-12 |
| 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 | 2020-03-12 |
| Model Number | NA |
| Catalog Number | CXI-4.0-35-90-P-NS-DAV |
| Lot Number | UNKNOWN |
| 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 | 1. Other | 2020-03-12 |