MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2019-05-14 for PULSION PULSIOCATH THERMODILUTION CATHETERS PV2015L20-A manufactured by Pulsion Medical Systems Se.
[144961147]
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
[144961148]
Acute ischemia in the leg after having placed picco catheter for 9 hours. The following actions have been taken: catheter removal, ct angiography, heparin and surgery with stent placement on artery dissection. No further clinical consequences occurred. Stabilized pathology and the patient is in good general condition. Manufacturer reference#: (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003263092-2019-00006 |
| MDR Report Key | 8607570 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2019-05-14 |
| Date of Report | 2019-07-22 |
| Date of Event | 2019-05-02 |
| Date Mfgr Received | 2019-07-18 |
| Date Added to Maude | 2019-05-14 |
| 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 | 2019-05-14 |
| Catalog Number | PV2015L20-A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PULSION MEDICAL SYSTEMS SE |
| Manufacturer Address | HANS-RIEDL-STRASSE 17 FELDKIRCHEN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-05-14 |