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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 Device Dislodged or Dislocated (2923)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/19/2023
Event Type  malfunction  
Event Description
It was reported that the blade was lifted.The target lesion was located in the left anterior descending artery (lad).A 10mmx3.25mm wolverine coronary cutting balloon was selected for use.During the procedure, the balloon was inflated 19 times at 20atm.The procedure was completed with this device.After the procedure was completed, it was found that the blade was lifted.There were no patient complications reported.
 
Manufacturer Narrative
E1: initial reporter city: (b)(6).
 
Event Description
It was reported that the blade was lifted.The target lesion was located in the left anterior descending artery (lad).A 10mmx3.25mm wolverine coronary cutting balloon was selected for use.During the procedure, the balloon was inflated 19 times at 20atm.The procedure was completed with this device.After the procedure was completed, it was found that the blade was lifted.There were no patient complications reported.It was further reported that the 90% stenosed target lesion was located in the moderately tortuous and severely calcified, with less than 90 degrees of angulation.
 
Manufacturer Narrative
E1.Initial reporter city: (b)(6).Device evaluated by manufacturer: the device was returned for analysis.Visual, tactile, microscopic analysis were performed on the device.A visual and tactile examination identified no damages on the hypotube shaft and shaft polymer extrusion.A visual examination identified that a blade was lifted.A detailed microscopic examination of the balloon material identified no issues.The balloon was returned in a deflated state.A microscopic examination of the blade segments identified the following: for the first blade, no damage was observed.Blade and pad fully bonded onto the balloon, two distal sections of the blades were lifted from the balloon on the second blade, and on the third blade, one segment of the blade was detached.A blade segment was returned which is likely to be the detached segment.The pad of the detached section was fully intact and bonded to the balloon.Approximately 2mm of the proximal blade section was detached and not returned with the distal part of the blade bonded to the pad and balloon.No issues identified during examination of the extrusion shaft.A microscopic examination of the tip section found no damage.
 
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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
rachel shields
4100 hamline ave n
arden hills, MN 55112
6512422111
MDR Report Key18479876
MDR Text Key332999061
Report Number2124215-2023-74451
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,Followup
Report Date 02/27/2024
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 Model Number3851
Device Catalogue Number3851
Device Lot Number0032531634
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/20/2023
Initial Date FDA Received01/09/2024
Supplement Dates Manufacturer Received02/06/2024
Supplement Dates FDA Received02/27/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/29/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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