MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-11-27 for BIOMEDICUS MULTISTAGE FEMORAL VENOUS CANNULA 96880-025 manufactured by Perfusion Systems.
[168780631]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[168780632]
Medtronic received information that during use, the customer reported bio-medicus multistage femoral venus cannula split during removal and they had to cut down the percutaneous insertion to expose the vessel to make removal easier. The product was replaced. The customer estimates the patient lost approximately 1liter of blood. The patient was on vv ecmo, stable but still critical due to the underlying respiratory failure. The split cannula section is still in the patient. Additional information: an emergency cannulation was performed during which a multistage femoral venous cannula was percutaneously inserted into the patients groin to provide venous drainage. The cannulation procedure involved dilating the vessel which passed without event. Upon inserting the cannula over the guidewire the clinician met resistance introducing the cannula. The customer hypothesizes that perhaps there was an issue passing the pelvic bone. The clinician attempted to pull back the cannula to try to re-insert/reposition, but it would not come back out of the vessel. It was lodged in the vessel. Blood loss occurred from the cannula connector end from the guidewire hole in the introducer, and also from the cannulation site on the patient. The customer estimates that approximately 1liter of blood was lost, perhaps more. The clinical team deduced that the cannula had actually been inserted into the femoral artery instead of the femoral vein. Hypothesizing that because saturations were low the blood was not easily identifiable as venous blood. Within 10 minutes a consultant cardiac surgeon removed the cannula using? Some force?. The cannula? Split? Leaving a section of the cannula in the patient. The cardiac surgeon had cut down the percutaneous insertion so they could expose the vessel to make removal easier. Upon pulling back on the cannula the surgeon could see that the inner wall of the vessel was also pulling back (confirming the cannula was lodged quite firmly). The patient was then put on vv ecmo using the jugular for drainage and the femoral vein to return blood to the right atrium (the other groin was used for this cannulation). The patient arrested whilst on vv ecmo. Patient was then put on vva ecmo to improve the patient? S condition. The patient is stable but still critical due to the underlying respiratory failure. The split cannula section is still in the patient. The patient does have some flow down their leg (confirmed by doppler / nirs) but their legs are in some difficulty (ischemic limbs). Customer cannot confirm if the leg issues are due to the cannula or previous hypoxic / respiratory critical illness. Vascular surgeons have been consulted regarding the cannula section removal.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2184009-2019-00077 |
| MDR Report Key | 9382426 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-11-27 |
| Date of Report | 2019-11-27 |
| Date of Event | 2019-11-16 |
| Date Mfgr Received | 2019-11-22 |
| Date Added to Maude | 2019-11-27 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | PAULA BIXBY |
| Manufacturer Street | 8200 CORAL SEA STREET NE |
| Manufacturer City | MOUNDS VIEW MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal | 55112 |
| Manufacturer Phone | 7635055378 |
| Manufacturer G1 | PERFUSION SYSTEMS |
| Manufacturer Street | 7611 NORTHLAND DR |
| Manufacturer City | BROOKLYN PARK MN 55428 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55428 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIOMEDICUS MULTISTAGE FEMORAL VENOUS CANNULA |
| Generic Name | CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS |
| Product Code | DWF |
| Date Received | 2019-11-27 |
| Model Number | 96880-025 |
| Catalog Number | 96880-025 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PERFUSION SYSTEMS |
| Manufacturer Address | 7611 NORTHLAND DR BROOKLYN PARK MN 55428 US 55428 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-11-27 |