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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 Entrapment of Device (1212)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/29/2023
Event Type  malfunction  
Event Description
It was reported that the device became stuck with the guidewire.The target lesion was located in the moderately calcified artery.A 10mmx3.25mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that the device got stuck with the guidewire.The catheter and guidewire had to be removed together as a single unit from the patient and the procedure was completed with another of the same device.There was no patient injury.
 
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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
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC IRELAND LIMITED
ballybrit business park
galway
EI  
Manufacturer Contact
jeff wallner
4100 hamline ave n
arden hills, MN 55112
6515811560
MDR Report Key16752968
MDR Text Key313811429
Report Number2124215-2023-17625
Device Sequence Number1
Product Code NWX
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation Physician
Type of Report Initial
Report Date 04/17/2023
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 Date07/08/2023
Device Model Number3851
Device Catalogue Number3851
Device Lot Number0027628149
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/29/2023
Initial Date FDA Received04/17/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/08/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
GUIDEWIRE - SION BLUE
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