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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Vascular Dissection (3160)
Event Date 10/16/2023
Event Type  Injury  
Manufacturer Narrative
A1: (b)(6).
 
Event Description
It was reported that a dissection occurred during the index procedure.The subject underwent treatment with two ranger drug-coated balloons on 16-oct-2023 as a part of the elegance clinical trial.The target lesion was in left distal superficial femoral artery extending up to left proximal popliteal artery with 6 mm proximal reference vessel diameter, 5 mm distal reference vessel diameter, and a lesion length of 60 mm.The lesion had 100% stenosis and was classified as tasc ii c lesion.Prior to target lesion treatment with study device, atherectomy was performed by using a 5.5 mm diameter non-boston scientific atherectomy device and pre-dilation was performed by using a 4.0 mm x 120 mm non-boston scientific percutaneous transluminal angioplasty (pta) balloon.Treatment of target lesion was performed by dilation using 5 mm x 120 mm and 6 mm x 100 mm ranger drug-coated balloons.Post-target lesion treatment was performed by placement of 5.0 mm x 40 mm innova drug-eluting stent and dilation using a 7.0 mm x 40 mm non-boston scientific percutaneous transluminal angioplasty (pta) balloon and a 5.0 mm x 120 mm non-boston scientific percutaneous transluminal angioplasty (pta) balloon.Following treatment, the final residual stenosis was noted to be 10%.On the same day of index procedure, during the treatment of the target lesion, a dissection (grade a) was observed related to 6.0 mm x 100 mm ranger drug-coated balloon treatment.In response to the event, additional balloon dilation was performed that resolved the issue.
 
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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 Key18240420
MDR Text Key329399523
Report Number2124215-2023-67559
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,Study,Health Professional
Reporter Occupation Physician
Type of Report Initial
Report Date 11/30/2023
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
Device Model Number1177-01
Device Catalogue Number1177-01
Device Lot Number03577H23
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/03/2023
Initial Date FDA Received11/30/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/21/2023
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Treatment
ATHERECTOMY DEVICE: 5.5 MM DIAMETER IVL BALLOON; BALLOON: 4.0 MM X 120 MM ARMADA PTA
Patient Outcome(s) Required Intervention;
Patient Age73 YR
Patient SexMale
Patient RaceWhite
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