MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,05,08 report with the FDA on 2013-11-06 for PLEURAFLOW SYS, 20FR PR-20 PF-20 manufactured by Xeridiem.
[18731895]
Incident occurred in the icu on a pt who had ha cabg surgery (lima to lad; vein grafts to the rca and rma). A pleuraflow (pf) act 20f was placed in the pericardial position behind the heart. Pt left the operating room on (b)(6) 2013. After a few hours, nurses could not move the wire within the chest tube. Built-in safety mechanism resulted in decoupling of the magnetic apparatus from the wire. Nurse called the attending surgeon who was able to actuate the wire "with patience" pulling it from a proximal position in the chest tube distally. Right after the surgeon actuated the wire, staff noticed blood collecting in the chest tubes and the canister. Pt became haemodynamically unstable with a drop in blood pressure. Pt's haemodynamic profile was stabilized with volume. Then, the attending surgeon decided to re-operate the pt in the icu. Upon exploration of the thoracic cavity, he noticed abrasion of the epicardial fat in the inferior wall of the right ventricle next to the chest tube, which led to venous bleeding. Bleeder was repaired with a suture and bleeding stopped. Pt recovered, did well and discharged from icu on (b)(6) 2013.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008782989-2013-00001 |
| MDR Report Key | 3653121 |
| Report Source | 00,01,05,08 |
| Date Received | 2013-11-06 |
| Date of Report | 2013-09-27 |
| Date of Event | 2013-09-26 |
| Date Mfgr Received | 2013-09-27 |
| Device Manufacturer Date | 2011-12-01 |
| Date Added to Maude | 2014-03-04 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Street | 62915 NE 18TH ST STE 5 |
| Manufacturer City | BEND OR 97701 |
| Manufacturer Country | US |
| Manufacturer Postal | 97701 |
| Manufacturer Phone | 5413822533 |
| Manufacturer Street | 4700 S OVERLAND DR |
| Manufacturer City | TUCSON AZ 85714 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 85714 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PLEURAFLOW SYS, 20FR |
| Generic Name | OTK AND GBX |
| Product Code | OTK |
| Date Received | 2013-11-06 |
| Returned To Mfg | 2013-10-14 |
| Model Number | PR-20 |
| Catalog Number | PF-20 |
| Lot Number | 8374-02 |
| Device Expiration Date | 2013-12-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | XERIDIEM |
| Manufacturer Address | 4700 S OVERLAND DR TUCSON AZ 85714 US 85714 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-11-06 |