MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2018-02-08 for PULSION PULSIOCATH THERMODILUTION CATHETERS PV2015L20N manufactured by Pulsion Medical Systems Se.
[99301393]
The involved picco catheter was returned for investigation. During investigation it could be detected that the lumen tubing of the catheter had a cut (1,7 cm) and a compression below the channel separation. The guide wire showed bends. A review of the dhr could not identify any non-conformities relevant to the reported issue. Difficulties during retraction of the guide wire are known complications during arterial catheterization and are promoted by the fact that the patient had very narrow vessels due to his physical constitution. Additionally, the compression of the tubing could have contributed to the impossibility of retraction. It is not known, how the compression occurred, but since the catheter could be inserted in the beginning without problems a manufacturing issue is considered as unlikely. Based on the issue description, experience and product investigation it is considered as likely that the user has applied excessive force during retracting of the guide wire and caused the cut in the tubing. The ifu have indications about the proceeding if resistance is encountered. Please note, (b)(4) (importer) is submitting the report on behalf of pulsion medical systems se (exemption number (b)(4)).
Patient Sequence No: 1, Text Type: N, H10
[99301394]
It was reported that the guide wire got stuck during retraction. Bleeding was detected (based on the hematoma likely more than 300 ml). A pressure bandage and transfusion was necessary. There was no further impact on the patient reported. Guide wire and catheter were then retracted simultaneously. Manufacturer reference #:(b)(4).
Patient Sequence No: 1, Text Type: D, B5
[113253780]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[113253781]
(b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003263092-2018-00002 |
| MDR Report Key | 7250686 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-02-08 |
| Date of Report | 2018-02-09 |
| Date of Event | 2018-01-09 |
| Date Mfgr Received | 2018-01-24 |
| Date Added to Maude | 2018-02-08 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| 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 | 2018-02-08 |
| Catalog Number | PV2015L20N |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | YR |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-02-08 |