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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SURFIRE MEDICAL INC SURFIRE INFUSION SYSTEM LT; Y90 CATHETER

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SURFIRE MEDICAL INC SURFIRE INFUSION SYSTEM LT; Y90 CATHETER Back to Search Results
Model Number SHF-38120-LT
Device Problems Occlusion Within Device (1423); Insufficient Flow or Under Infusion (2182)
Patient Problem Thrombus (2101)
Event Date 02/26/2016
Event Type  Other  
Event Description
During delivery of y90 theraspheres for treatment of liver hepatocellular carcinoma, it was discovered that pt received only about 15% of planned dose while remaining dose remained in catheter.Review with surfire rep and felt that clotting of catheter may have been a result of apparatus not fully extended, providing occlusion.
 
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Brand Name
SURFIRE INFUSION SYSTEM LT
Type of Device
Y90 CATHETER
Manufacturer (Section D)
SURFIRE MEDICAL INC
MDR Report Key5522256
MDR Text Key41142926
Report NumberMW5061222
Device Sequence Number1
Product Code DQO
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 03/10/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date08/01/2016
Device Model NumberSHF-38120-LT
Device Lot Number140529L
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/22/2016
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age70 YR
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