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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RANGER; CATHETER, PERCUTANEOUS
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BOSTON SCIENTIFIC CORPORATION RANGER; CATHETER, PERCUTANEOUS Back to Search Results
Model Number 1177-01
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Failure to Deflate (4060)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/25/2024
Event Type  Injury  
Event Description
It was reported that deflation failure occurred.An 8.0 mm x 40 mm, 135cm ranger drug-coated balloon (dcb) catheter was advanced for dilation along with a 7fr non-boston scientific sheath.During the procedure, the balloon was able to inflate and deflate at first.Upon second use, the balloon inflation was good, but could no longer be deflated.Due to repeated attempts, the physician had to puncture the balloon with a fine needle from the outside through the skin to destroy it.After that, the device was then removed through the sheath.The procedure was completed, and no patient complications were reported.
 
Event Description
It was reported that deflation failure occurred.An 8.0 mm x 40 mm, 135cm ranger drug-coated balloon (dcb) catheter was advanced for dilation along with a 7fr non-boston scientific sheath.During the procedure, the balloon was able to inflate and deflate at first.Upon second use, the balloon inflation was good, but could no longer be deflated.Due to repeated attempts, the physician had to puncture the balloon with a fine needle from the outside through the skin to destroy it.After that, the device was then removed through the sheath.The procedure was completed, and no patient complications were reported.It was further reported that the stenosed target lesion was 70% calcified, straight vessel in the superficial femoral artery.
 
Manufacturer Narrative
Correction of h6 impact codes of additional device required, f2301 to unexpected medical intervention, f23.Device evaluated by mfr: the ranger device was returned for analysis.A visual examination of the returned device found that the balloon had been inflated and was not refolded.It is not known when the balloon was subjected to positive pressure.The balloon was unable to be inflated due to the multiple shaft kinks.The markerbands and tip section of the device were visually examined, and no issues were noted with the markerbands or tip of the device.A visual and tactile examination of the shaft found multiple shaft kinks.The inner shaft was also noted to be damaged.
 
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Brand Name
RANGER
Type of Device
CATHETER, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
HEMOTEQ AG
adenauerstrasse 15
wuerselen 52146
GM   52146
Manufacturer Contact
rachel shields
4100 hamline ave n
arden hills, MN 55112
6512422111
MDR Report Key19153989
MDR Text Key340728679
Report Number2124215-2024-22779
Device Sequence Number1
Product Code ONU
Combination Product (y/n)Y
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 05/13/2024
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 Model Number1177-01
Device Catalogue Number1177-01
Device Lot Number05455H23
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/22/2024
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/26/2024
Initial Date FDA Received04/22/2024
Supplement Dates Manufacturer Received04/22/2024
Supplement Dates FDA Received05/13/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/15/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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