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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 Problem Inflation Problem (1310)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/15/2024
Event Type  malfunction  
Event Description
It was reported that the procedure was cancelled.The target lesion was located in the superficial femoral artery.After atherectomy was performed, a 5x200mm, 150cm ranger drug-coated balloon (dcb) catheter was advanced for treatment.During the procedure, the balloon was inflated twice up to rated burst pressure, but it did not inflate.No visible pinhole was noted on the balloon material, but the procedure was not completed due to this event.It was unknown if the patient was sedated with local or general anesthesia.No complications were reported.
 
Event Description
It was reported that the procedure was cancelled.The target lesion was located in the superficial femoral artery.After atherectomy was performed, a 5x200mm, 150cm ranger drug-coated balloon (dcb) catheter was advanced for treatment.During the procedure, the balloon was inflated twice up to rated burst pressure, but it did not inflate.No visible pinhole was noted on the balloon material, but the procedure was not completed due to this event.It was unknown if the patient was sedated with local or general anesthesia.No complications were reported.It was further reported that the lesion was 70 to 80% stenosed, was mildly tortuous, and had severe (hard) calcification.It was also noted that the device was not used within a placed stent.
 
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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 Key19116781
MDR Text Key340285878
Report Number2124215-2024-22493
Device Sequence Number1
Product Code ONU
Combination Product (y/n)Y
Reporter Country CodeKS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 05/15/2024
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 Model Number1177-01
Device Catalogue Number1177-01
Device Lot Number06529H23
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/19/2024
Initial Date FDA Received04/16/2024
Supplement Dates Manufacturer Received04/19/2024
Supplement Dates FDA Received05/15/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/14/2023
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 Age81 YR
Patient SexFemale
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