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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 Difficult to Remove (1528); Difficult to Advance (2920); Material Deformation (2976); Material Twisted/Bent (2981)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/27/2021
Event Type  malfunction  
Event Description
It was reported that the ranger was difficult to remove.A 4.00mm x 150mm, 150cm ranger sl drug-coated balloon was selected for use in a below-the-knee angioplasty procedure in the superficial femoral artery.The 60% stenosed target lesion was mildly calcified and located in mildly tortuous anatomy.The balloon was flushed from both ports, and the v-18 controlwire guidewire was wetted.The ranger was placed on the end of the wire and advanced.There was a little resistance, so a wet gauze was used on the v-18 controlwire.It then became difficult to advance the balloon.It was noted that the end of the balloon had twisted and accordioned on itself.An attempt was made to remove the balloon from the wire without losing access, but it was very difficult.The ranger was ultimately pulled off of the wire with a lot of force.The v-18 controlwire was exchanged for an extra support wire.No patient complications were reported.
 
Event Description
It was reported that the ranger was difficult to remove.A 4.00mm x 150mm, 150cm ranger sl drug-coated balloon was selected for use in a below-the-knee angioplasty procedure in the superficial femoral artery.The 60% stenosed target lesion was mildly calcified and located in mildly tortuous anatomy.The balloon was flushed from both ports, and the v-18 controlwire guidewire was wetted.The ranger was placed on the end of the wire and advanced.There was a little resistance, so a wet gauze was used on the v-18 controlwire.It then became difficult to advance the balloon.It was noted that the end of the balloon had twisted and accordioned on itself.An attempt was made to remove the balloon from the wire without losing access, but it was very difficult.The ranger was ultimately pulled off of the wire with a lot of force.The v-18 controlwire was exchanged for an extra support wire.No patient complications were reported.
 
Manufacturer Narrative
Device eval by manufacturer: returned product consisted of a ranger sl drug-coated balloon catheter.The outer shaft, inner shaft, balloon, and tip were visually and microscopically examined.Visual examination revealed buckling to the guidewire lumen 5mm from the strain relief and 6mm from the tip.The distal section of the balloon was deformed.The guidewire lumen was separated 18.4cm from the tip.The inflation lumen was damaged at the location of the separation.Microscopic examination revealed no additional damages.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis found damage that would have contributed to the reported event.
 
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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
MDR Report Key12022162
MDR Text Key257216937
Report Number2134265-2021-07790
Device Sequence Number1
Product Code ONU
Combination Product (y/n)Y
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 08/27/2021
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 Date10/13/2022
Device Model Number1584-01
Device Catalogue Number1584-01
Device Lot Number07149H20
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/21/2021
Initial Date Manufacturer Received 05/27/2021
Initial Date FDA Received06/17/2021
Supplement Dates Manufacturer Received08/12/2021
Supplement Dates FDA Received08/27/2021
Patient Sequence Number1
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