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 2018-09-07 for PULSION PULSIOCATH THERMODILUTION CATHETERS PV2014L22N manufactured by Pulsion Medical Systems Se.
[119561152]
Further information surrounding the event has been sought. The involved guide wire has been requested for further investigation. Investigation is ongoing at the moment. A supplemental medwatch report will be sent when the investigation is completed. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[119561153]
It was reported that during insertion of catheter the guide wire fractured and the tip of the guide wire remained in the patient. The tip had to be removed surgically. No further harm came to the patient. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003263092-2018-00007 |
| MDR Report Key | 7856427 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-09-07 |
| Date of Report | 2018-11-26 |
| Date Facility Aware | 2018-11-26 |
| Date Mfgr Received | 2018-08-22 |
| Date Added to Maude | 2018-09-07 |
| 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 | 3 |
| Brand Name | PULSION PULSIOCATH THERMODILUTION CATHETERS |
| Generic Name | PROBE, THERMODILUTION |
| Product Code | KRB |
| Date Received | 2018-09-07 |
| Catalog Number | PV2014L22N |
| Lot Number | 614179 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 1. Required No Informationntervention | 2018-09-07 |