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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC CORPORATION WOLVERINE CORONARY CUTTING BALLOON MONORAIL; CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING Back to Search Results
Model Number 3851
Device Problem Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/09/2022
Event Type  malfunction  
Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.A visual and tactile examination of the hypotube identified no kinks or damages.A visual and microscopic examination of the distal extrusion identified that a break had occurred in the extrusion.The break was located approximately 12.9cm distal from the proximal edge of the midshaft.The distal section of the break including the distal extrusion, balloon and tip were not returned for analysis.No other issues were identified during the product analysis.
 
Event Description
Reportable based on device analysis completed on 16aug2022.It was reported that the delivery shaft was kinked.The 92% stenosed, 11mmx2.75mm target lesion was located in the moderately tortuous and calcified left anterior descending artery.A 10mmx2.75mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that the delivery shaft was kinked.The procedure was completed with a different device.There were no complications reported and the patient was stable post procedure.However, device analysis revealed that a break had occurred in the extrusion approximately at 12.9cm distal from the proximal edge of the midshaft.
 
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Brand Name
WOLVERINE CORONARY CUTTING BALLOON MONORAIL
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 IRELAND LIMITED
ballybrit business park
galway
EI  
Manufacturer Contact
jay johnson
4100 hamline ave n
arden hills, MN 55112
6515810888
MDR Report Key15294526
MDR Text Key305500412
Report Number2134265-2022-08676
Device Sequence Number1
Product Code NWX
Combination Product (y/n)N
Reporter Country CodeCH
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation Physician
Type of Report Initial
Report Date 08/25/2022
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 Expiration Date11/09/2023
Device Model Number3851
Device Catalogue Number3851
Device Lot Number0028360116
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/19/2022
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/16/2022
Initial Date FDA Received08/25/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/09/2021
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 Age58 YR
Patient SexMale
Patient Weight78 KG
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