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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RANGER SL; CATHETER, PERCUTANEOUS
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BOSTON SCIENTIFIC CORPORATION RANGER SL; CATHETER, PERCUTANEOUS Back to Search Results
Model Number 1584-01
Device Problems Break (1069); Device Difficult to Setup or Prepare (1487)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/28/2022
Event Type  malfunction  
Event Description
It was reported that the balloon broke.A 2.50mm x 80mm, 150cm ranger sl drug-coated balloon was selected for use in a vascular intervention.During preparation, the balloon became stuck in the loading tool.When trying to pull the device out, the balloon broke because it was stuck in the tool.The device was not used in the procedure.The procedure was completed with another device.No patient complications were reported.
 
Manufacturer Narrative
Date of event: event date was not reported and was approximated to (b)(6) 2022.
 
Event Description
It was reported that the balloon broke.A 2.50mm x 80mm, 150cm ranger sl drug-coated balloon was selected for use in a vascular intervention.During preparation, the balloon became stuck in the loading tool.When trying to pull the device out, the balloon broke because it was stuck in the tool.The device was not used in the procedure.The procedure was completed with another device.No patient complications were reported.It was further clarified that the balloon was introduced into the sheath, but the loading tool remained stuck on the balloon part and could not be removed.The device broke at the junction of the proximal loading tool, but did not separate into pieces.
 
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Brand Name
RANGER SL
Type of Device
CATHETER, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
HEMOTEQ AG
adenauerstrasse 15
wuerselen 52146
GM   52146
Manufacturer Contact
jay johnson
4100 hamline ave n
arden hills, MN 55112
6515810888
MDR Report Key14578349
MDR Text Key293273606
Report Number2134265-2022-06211
Device Sequence Number1
Product Code ONU
Combination Product (y/n)Y
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 08/09/2022
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? Yes
Device Operator Health Professional
Device Expiration Date04/16/2023
Device Model Number1584-01
Device Catalogue Number1584-01
Device Lot Number02492H21
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/11/2022
Initial Date FDA Received06/02/2022
Supplement Dates Manufacturer Received07/13/2022
Supplement Dates FDA Received08/09/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/16/2021
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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