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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 Unsealed Device Packaging (1444); Device Contamination with Chemical or Other Material (2944); Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/20/2022
Event Type  malfunction  
Event Description
It was reported that the sterile packaging was not sealed and the balloon was damaged/defective.A ranger sl drug-coated 3.0mm x 150mm, 150cm balloon catheter was selected for this below-the-knee endovascular procedure.Prior to the procedure, it was noticed that the outer plastic had been opened, however, the blue tag seal was intact on the box.Upon opening the box, the sterile packaging on the inside was not sealed and the balloon had a water-like fluid inside and appeared not fully wrapped.The device was not used, and the procedure was completed successfully using an alternative device.No reported patient complications.
 
Event Description
It was reported that the sterile packaging was not sealed and the balloon was damaged/defective.A ranger sl drug-coated 3.0mm x 150mm, 150cm balloon catheter was selected for this below-the-knee endovascular procedure.Prior to the procedure, it was noticed that the outer plastic had been opened, however, the blue tag seal was intact on the box.Upon opening the box, the sterile packaging on the inside was not sealed and the balloon had a water-like fluid inside and appeared not fully wrapped.The device was not used, and the procedure was completed successfully using an alternative device.No reported patient complications.
 
Manufacturer Narrative
Device eval by manufacturer: the returned product consisted of a ranger sl drug coated balloon catheter still inside the product pouch and still inside the shelf box.The packaging was visually inspected and there does not appear to have been any tampering with the packaging.The seal on the shelf box and the product pouch was open using the intended methods.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual and microscopic examination revealed no damages.The device has blood on it and there is contrast present inside the balloon.The balloon is loosely folded and the drug coating was no longer present.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed that the seals to the packaging are open, and the device has been used.
 
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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 Key15986941
MDR Text Key306244983
Report Number2124215-2022-50324
Device Sequence Number1
Product Code ONU
Combination Product (y/n)Y
Reporter Country CodeSF
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/17/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/15/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/23/2024
Device Model Number1584-01
Device Catalogue Number1584-01
Device Lot Number01723H22
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/25/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/23/2022
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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