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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
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Vascular Dissection (3160)
Event Date 08/23/2023
Event Type  Injury  
Manufacturer Narrative
A1: patient identifier- (b)(6).A2: patient age at the time of enrollment- 85 years old.
 
Event Description
Elegance study it was reported that a dissection of grade d occurred.The subject underwent treatment with the ranger drug-coated balloons and eluvia drug-eluting stents on (b)(6) 2023 as a part of the elegance clinical trial.The target lesion was in the right proximal superficial femoral artery, right mid superficial femoral artery extending up to right distal superficial femoral artery with 7 mm proximal reference vessel diameter and 7 mm distal reference vessel diameter with lesion length 250 mm with 90% stenosis and was classified as tasc ii b lesion.Prior to the treatment of target lesion with study device, lithotripsy was performed by using 6 mm x 60 mm non-boston scientific (bsc) lithotripsy device.Treatment of the target lesion was performed by dilation using study devices, 6 mm x 200 mm and 6 mm x 100 mm ranger drug-coated balloons followed by the placement of two 7 mm x 120 mm eluvia drug-eluting stents.Following treatment, the final residual stenosis was noted to be 0%.On (b)(6) 2023, on the same day of index procedure, during the treatment of the target lesion, dissection of grade d was noted in the target lesion due to 6 mm x 200 mm ranger drug-coated balloon.In response to the complication, a bailout stent was placed.Post treatment, the final residual stenosis was noted to be 0%.On (b)(6) 2023, the complication of dissection was resolved.On the same day, the subject was discharged from hospital on aspirin and clopidogrel.
 
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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
GM  
Manufacturer Contact
rachel shields shields
4100 hamline ave n
arden hills, MN 55112
6512422111
MDR Report Key17835350
MDR Text Key324493570
Report Number2124215-2023-52351
Device Sequence Number1
Product Code ONU
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Study,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 09/28/2023
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? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/06/2023
Initial Date FDA Received09/28/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient SexMale
Patient RaceWhite
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