MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-09 for PULSION PULSIOCATH THERMODILUTION CATHETERS PV2014L16N manufactured by Pulsion Medical Systems Se.
[133214988]
Further information has been requested and investigation is ongoing. A supplemental medwatch report will be sent when the investigation is completed. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[133214989]
After placing the catheter the guide wire was retracted. During retraction of the guide wire it was detected that the guide wire was broken. The complete guide wire was removed from patient with the catheter. No clinical consequences or harm to the patient occurred; a new catheter was inserted. Manufacturer reference#: (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003263092-2019-00001 |
| MDR Report Key | 8231676 |
| Date Received | 2019-01-09 |
| Date of Report | 2019-05-14 |
| Date of Event | 2018-02-04 |
| Date Mfgr Received | 2019-05-14 |
| Device Manufacturer Date | 2017-01-31 |
| Date Added to Maude | 2019-01-09 |
| 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 Street | PULSION MEDICAL SYSTEMS SE HANS-RIEDL-STR. 21 |
| Manufacturer City | 85622 FELDKIRCHEN |
| Manufacturer Country | GM |
| Manufacturer Phone | 0498945991 |
| Manufacturer G1 | CHRISTINA KOEBERL |
| Manufacturer Street | PULSION MEDICAL SYSTEMS SE HANS-RIEDL-STR. 21 |
| Manufacturer City | 85622 FELDKIRCHEN |
| Manufacturer Country | GM |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PULSION PULSIOCATH THERMODILUTION CATHETERS |
| Generic Name | PROBE, THERMODILUTION |
| Product Code | KRB |
| Date Received | 2019-01-09 |
| Returned To Mfg | 2019-01-14 |
| Catalog Number | PV2014L16N |
| Lot Number | 619481 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | YR |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PULSION MEDICAL SYSTEMS SE |
| Manufacturer Address | PULSION MEDICAL SYSTEMS SE HANS-RIEDL-STR. 21 85622 FELDKIRCHEN GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-09 |