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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 Entrapment of Device (1212); Difficult to Advance (2920); Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/30/2024
Event Type  malfunction  
Event Description
It was reported that the balloon got stuck with the guidewire.A 300cm, 8cm v-18 control wire and 4x200mm, 150cm ranger drug-coated balloon were selected for femoral angioplasty.During the procedure, it was noted that the balloon got stuck when passing over the guidewire.When the balloon was attempted to be retracted, the balloon was damaged.Both devices were removed together, and the procedure was completed using an alternate device.There were no patient complications.
 
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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 Key19130462
MDR Text Key340455241
Report Number2124215-2024-21248
Device Sequence Number1
Product Code ONU
Combination Product (y/n)Y
Reporter Country CodeCI
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
Report Date 04/17/2024
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 Number07819H22
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/26/2024
Initial Date FDA Received04/18/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/21/2022
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 SexFemale
Patient RaceWhite
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