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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION STINGRAY LP CATHETER; CATHETER, PERCUTANEOUS
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BOSTON SCIENTIFIC CORPORATION STINGRAY LP CATHETER; CATHETER, PERCUTANEOUS Back to Search Results
Model Number 10595
Device Problems Inflation Problem (1310); Material Integrity Problem (2978)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/13/2020
Event Type  malfunction  
Event Description
It was reported that the procedure was not completed.The 95% stenosed target lesion was located in left anterior descending artery.A stingray lp catheter was selected for use.During procedure, it was noted that the balloon failed to inflate and recognize under scope.The device was simply removed from the patient's body and procedure could not be completed.There were no complications reported and patient was stable.
 
Manufacturer Narrative
Device evaluated by mfr: the device was returned for analysis.The shaft, hypotube, tip and balloon were microscopically and visually examined.There was contrast in the inflation lumen and balloon, and blood in the guidewire lumen.The balloon was loosely folded.The device was soaked in a water bath for 14 days to loosen the blood and contrast in the device.The device was prepped with an inflation device filled with water and connected to the inflation port to inflate the device.There were no issues detected.The device was x-rayed, and the marker bands were detected.Inspection of the remainder of the device presented no other damage or irregularities.
 
Event Description
It was reported that the procedure was not completed.The 95% stenosed target lesion was located in left anterior descending artery.A stingray lp catheter was selected for use.During procedure, it was noted that the balloon failed to inflate and recognize under scope.The device was simply removed from the patient's body and procedure could not be completed.There were no complications reported and patient was stable.
 
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Brand Name
STINGRAY LP CATHETER
Type of Device
CATHETER, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key10635822
MDR Text Key210058929
Report Number2134265-2020-13707
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 11/25/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/06/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/28/2021
Device Model Number10595
Device Catalogue Number10595
Device Lot Number0024350350
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/02/2020
Date Manufacturer Received11/12/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age52 YR
Patient Weight70
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