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 2020-02-24 for CROSSCATH SUPPORT CATHETER G51574 CXC3.0-1.9-14-150-P-NS-0 manufactured by Cook Inc.
[183797883]
Occupation = unknown. Pma/510(k) number = k161801. 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
[183797884]
As reported, during an interventional procedure of the left superficial femoral and popliteal arteries via access in the right common femoral artery, two crosscath support catheters were perforated while crossing the lesion within the superficial femoral artery. The patient is reportedly "good". 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 | 1820334-2020-00438 |
| MDR Report Key | 9746083 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2020-02-24 |
| Date of Report | 2020-03-13 |
| Date of Event | 2020-02-19 |
| Date Mfgr Received | 2020-02-21 |
| Device Manufacturer Date | 2019-10-07 |
| Date Added to Maude | 2020-02-24 |
| 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 | CROSSCATH SUPPORT CATHETER |
| Generic Name | KRA CATHETER, CONTINUOUS FLUSH |
| Product Code | KRA |
| Date Received | 2020-02-24 |
| Returned To Mfg | 2020-03-04 |
| Model Number | G51574 |
| Catalog Number | CXC3.0-1.9-14-150-P-NS-0 |
| Lot Number | 10065325 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| 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. Required No Informationntervention | 2020-02-24 |