MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-20 for PWP CATHETER 150075 manufactured by Medtronic, Inc.
[184314604]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[184314605]
Three pulmonary wedge pressure catheter were attempted to be used during a procedure to treat a non tortuous, non calcified veinous system in the right hearth cath. There was no damage noted to the packaging of the devices. The devices were removed from packaging per ifu with no issues. The devices were inspected with no issues. It was reported that an attempt was made to float the pulmonary wedge pressure catheter with the balloon inflated through a previously implanted venous stent and the stent struts burst the balloon. The procedure was complete by passing another pulmonary wedge pressure catheter uninflated through the stent. It was reported that there was no issue with the catheters that had the ruptured balloons. The patient is alive with no injury.
Patient Sequence No: 1, Text Type: D, B5
[188520274]
It was reported that the unknown brand venous stent looked ok after interaction with the pulmonary wedge pressure balloons. The usual medium, and volume of medium (mls) was used as with several other successful procedures. The physician assessed that the venous stent caused the ruptured balloons. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1220452-2020-00035 |
| MDR Report Key | 9859268 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-20 |
| Date of Report | 2020-03-25 |
| Date of Event | 2020-03-12 |
| Date Mfgr Received | 2020-03-20 |
| Device Manufacturer Date | 2019-08-14 |
| Date Added to Maude | 2020-03-20 |
| 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 Contact | TONI O'DOHERTY |
| Manufacturer Street | PARKMORE BUSINESS PARK WEST |
| Manufacturer City | GALWAY |
| Manufacturer Phone | 091708734 |
| Manufacturer G1 | MEDTRONIC, INC |
| Manufacturer Street | 37A CHERRY HILL DR |
| Manufacturer City | DANVERS MA 01923 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01923 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PWP CATHETER |
| Generic Name | CATHETER, INTRAVASCULAR, DIAGNOSTIC |
| Product Code | DQO |
| Date Received | 2020-03-20 |
| Model Number | 150075 |
| Catalog Number | 150075 |
| Lot Number | 0009874487 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC, INC |
| Manufacturer Address | 37A CHERRY HILL DR DANVERS MA 01923 US 01923 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-20 |