MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-09 for COAXIAL UMBILICAL CABLE 203CX manufactured by Medtronic Cryocath Lp.
[38584510]
This event occurred outside the us where the same model is distributed. All information provided is included in this report. Patient information is not generally available due to confidentiality concerns. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[38584511]
It was reported that during a cryo ablation procedure, two system notices were displayed indicating the safety system detected fluid in the catheter and stopped the injection and the safety system detected blood in the catheter handle, the injection was stopped and the vacuum disabled. Blood was also reported to be visible in the catheter and coaxial umbilical cable connector. The catheter was replaced but the procedure was completed with radiofrequency. No patient complications have been reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[39809412]
Patient Sequence No: 1, Text Type: N, H10
[44197217]
Product event summary: the data files for the date of the reported event and the coaxial umbilical cable, 203cx with an unknown lot, were returned and analyzed. The data files confirmed the reported 50005 system notice indicating? Leak detection? , and the reported 50006 system notice indicating? Blood detection?. It was noted that the data files also showed two system notices unrelated to the reported issue. Visual inspection of the coaxial umbilical cable showed traces of blood on the coaxial connector and within the vacuum tube and the injection line. In conclusion, the reported 50005 and 50006 system notices were confirmed through testing and through data analysis. The coaxial umbilical cable, 203cx with an unknown lot, failed the visual inspection due to the presence of blood in the vacuum and injection lines.
Patient Sequence No: 1, Text Type: N, H10
[104703148]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002648230-2016-00037 |
| MDR Report Key | 5418751 |
| Date Received | 2016-02-09 |
| Date of Report | 2016-01-13 |
| Date of Event | 2016-01-12 |
| Date Mfgr Received | 2016-03-30 |
| Date Added to Maude | 2016-02-09 |
| 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 | ANNE SCHILLING |
| Manufacturer Street | 8200 CORAL SEA ST NE |
| Manufacturer City | MOUNDS VIEW MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal | 55112 |
| Manufacturer Phone | 7635052036 |
| Manufacturer G1 | MEDTRONIC CARDIAC RHYTHM HEART FAILURE |
| Manufacturer Street | 8200 CORAL SEA ST NE |
| Manufacturer City | MOUNDS VIEW MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55112 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COAXIAL UMBILICAL CABLE |
| Generic Name | CABLE |
| Product Code | ISN |
| Date Received | 2016-02-09 |
| Returned To Mfg | 2016-02-09 |
| Model Number | 203CX |
| Catalog Number | 203CX |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC CRYOCATH LP |
| Manufacturer Address | 16771 CHEMIN STE-MARIE KIRKLAND H9H 5H3 CA H9H 5H3 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-02-09 |