MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-07 for PULSION PULSIOCATH THERMODILUTION CATHETERS PV2015L20-A manufactured by Christina Koeberl.
[119796601]
Further information surrounding the event has been sought. The involved guidewire has been discarded by the user. 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
[119796602]
It was reported that during retraction of the guide wire, the guide wire got stuck inside the catheter. During complete removal with force the catheter got damaged. There were no clinical consequences for the patient. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003263092-2018-00008 |
| MDR Report Key | 7856432 |
| Date Received | 2018-09-07 |
| Date of Report | 2019-01-15 |
| Date Mfgr Received | 2018-08-21 |
| 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 |
| Reporter Occupation | PHARMACIST |
| 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 | 2018-09-07 |
| Catalog Number | PV2015L20-A |
| Lot Number | 619571 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CHRISTINA KOEBERL |
| Manufacturer Address | PULSION MEDICAL SYSTEMS SE HANS-RIEDL-STR. 21 85622 FELDKIRCHEN GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-09-07 |