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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 Failure to Deflate (4060)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/21/2024
Event Type  Injury  
Event Description
It was reported that balloon deflation failure occurred resulting to additional device intervention.The 70% stenosed target lesion was located in the non-tortuous and non-calcified vessel.A 7.0mm x 40mm, 80cm ranger drug-coated balloon was selected for angioplasty.However, it was noted that the balloon did not deflate during removal, forcing the operator to remove the introducer and pierce the balloon in order to successfully remove it.The procedure was completed using a non-bsc device.No patient complications reported.
 
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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 Key19139783
MDR Text Key340561047
Report Number2124215-2024-21612
Device Sequence Number1
Product Code ONU
Combination Product (y/n)Y
Reporter Country CodeFR
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 04/18/2024
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 Number07643H23
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 Manufactured08/18/2023
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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