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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RANGER SL; CATHETER, PERCUTANEOUS
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RANGER SL; CATHETER, PERCUTANEOUS Back to Search Results
Model Number 1584-01
Device Problems Deflation Problem (1149); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hemorrhage/Bleeding (1888); Perforation of Vessels (2135); Obstruction/Occlusion (2422)
Event Date 07/15/2021
Event Type  Injury  
Event Description
It was reported that vessel occlusion and vessel damage occurred.The 80% stenosed target vessel was located in the moderately calcified and mildly tortuous anterior tibial artery.Pre-dilation was successfully performed with a 2.0 x 150 sterling balloon catheter.Then, a 2.5 x 150 ranger sl drug-coated balloon was advanced and inflated to 6 atmospheres for 3 minutes.When attempting to deflate the balloon, the balloon would not deflate.Several methods to deflate the balloon were tried, including changing the inflation device, using a 60ml syringe and a three way stop-cock, all without success.After 15 minutes, the balloon was withdrawn while inflated and the procedure was terminated.Angiographic imaging showed slow blood flow in the anterior tibial artery and injury to the inner layer of the vessel.The patient received anticoagulation medication.No further patient complications were reported.The patient is in stable condition.
 
Manufacturer Narrative
H3 - device evaluated 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 multiple stretched sections to the inflation lumen.The guidewire lumen is separated 149.5cm from the hub and 18.5cm from the tip.The guidewire lumen is wavy distal of the separation and the balloon is partially pulled over the tip.There are multiple kinks to the inflation lumen.The balloon protector was not removed and is sitting on the inflation lumen.Microscopic examination revealed that the tip is damaged.Inspection of the remainder of the device presented no other damage or irregularities.
 
Event Description
It was reported that vessel occlusion and vessel damage occurred.The 80% stenosed target vessel was located in the moderately calcified and mildly tortuous anterior tibial artery.Pre-dilation was successfully performed with a 2.0 x 150 sterling balloon catheter.Then, a 2.5 x 150 ranger sl drug-coated balloon was advanced and inflated to 6 atmospheres for 3 minutes.When attempting to deflate the balloon, the balloon would not deflate.Several methods to deflate the balloon were tried, including changing the inflation device, using a 60ml syringe and a three way stop-cock, all without success.After 15 minutes, the balloon was withdrawn while inflated and the procedure was terminated.Angiographic imaging showed slow blood flow in the anterior tibial artery and injury to the inner layer of the vessel.The patient received anticoagulation medication.No further patient complications were reported.The patient is in stable condition.It was further reported that blood loss occurred, however, the amount lost was insignificant.
 
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Brand Name
RANGER SL
Type of Device
CATHETER, PERCUTANEOUS
MDR Report Key12337612
MDR Text Key267100384
Report Number2134265-2021-09955
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 10/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/11/2023
Device Model Number1584-01
Device Catalogue Number1584-01
Device Lot Number00263H21
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/21/2021
Initial Date Manufacturer Received 08/02/2021
Initial Date FDA Received08/18/2021
Supplement Dates Manufacturer Received09/27/2021
Supplement Dates FDA Received10/19/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/11/2021
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age65 YR
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