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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WOLVERINE CORONARY CUTTING BALLOON; CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING

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BOSTON SCIENTIFIC CORPORATION WOLVERINE CORONARY CUTTING BALLOON; CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING Back to Search Results
Model Number 3854
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Thrombosis/Thrombus (4440)
Event Date 06/17/2022
Event Type  Injury  
Event Description
Agent ide study.It was reported that thrombus occurred.The subject presented emergently with the complaints of chest pain and shortness of breath and was hospitalized for further treatment and evaluation.A physical examination revealed chest pain, dyspnea on exertion, orthopnea and paroxysmal nocturnal dyspnea, shortness of breath and muscle cramps.At the time of the event, the subject was on aspirin and ticagrelor.Diagnostic catheterization, ivus and optical coherence tomography were performed as the diagnostics for the event.The subject was diagnosed with ccs ii typical angina.The 90% restenosis in the proximal circumflex (lcx) was treated using a 12 x 2.50 mm mm emerge monorail balloon, followed by treatment with 10 x 3.50 mm wolverine monorail cutting balloon and 15 x 4.00 mm nc non boston scientific (bsc) balloon.Following this, a 15 x 4.00 mm nc non bsc balloon was inflated and the target lesion was treated with a 20 x 4.00 mm agent dcb study device.Post revascularization 30% residual stenosis was noted with timi flow 3.Optical coherence tomography (oct) was performed, which showed thrombus/neointimal flap associated with the ostial lcx stent but protruding into the distal left main coronary artery (lmca).Ballooning from the lmca to left anterior descending artery (lad) did not resolve the thrombus.A 0.9 mm x 135 mm non bsc ultraviolet laser was used on the lcx and lad.A 10 x 3.50 mm wolverine monorail cutting balloon and a 15 x 4.00 mm nc non-bsc balloon were inflated at the proximal lad.Ivus was performed and an 8 x 5.00 mm nc quantum apex mr balloon was inflated in the lad.The event was also treated medically.The next day, the event was considered to be recovered/resolved and the subject was discharged on the same day to home on eliquis and ticagrelor.
 
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Brand Name
WOLVERINE CORONARY CUTTING BALLOON
Type of Device
CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
ballybrit business park
galway
EI  
Manufacturer Contact
jay johnson
4100 hamline ave n
arden hills, MN 55112
6515810888
MDR Report Key15420444
MDR Text Key299888183
Report Number2124215-2022-35290
Device Sequence Number1
Product Code NWX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P950020
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 09/14/2022
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 Number3854
Device Catalogue Number3854
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/29/2022
Initial Date FDA Received09/14/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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) Other; Required Intervention;
Patient Age78 YR
Patient SexMale
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