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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 3852
Device Problems Break (1069); Difficult to Remove (1528)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/01/2023
Event Type  malfunction  
Event Description
It was reported that there was slight resistance upon removal and device broke.The 70% stenosed target lesion was located in the mildly tortuous and moderately calcified middle left anterior descending artery.A 15mmx3.00mm wolverine coronary cutting balloon was selected for use.Upon withdrawal, there was slight resistance when attempting to remove the device.Then, the device broke upon a gentle subsequent attempt and the procedure was completed with another of the same device.No complications reported and patient was stable.
 
Manufacturer Narrative
E1.Initial reporter address 1: (b)(6).
 
Manufacturer Narrative
E1.Initial reporter address 1- (b)(6).Device evaluated by manufacturer: the device was returned for analysis.A visual and tactile examination identified a hypotube kink.A visual and tactile examination identified damage with a break and stretching.A visual examination of the tip noted the tip was inverted inside the balloon.A microscopic examination identified a hypotube kink at 119cm distal to the distal end of the strain relief.A microscopic examination identified stretching on the polymer extrusion and as a result of this stretching the proximal markerband was positioned at the proximal edge of the proximal balloon sleeve.In addition, a break was noted at the site of the exchange port.A detailed microscopic examination of the balloon material identified no tears or pinholes in the balloon.All blades were fully bonded on the balloon and did not exhibit any signs of damage.Microscopic examination of tip noted that due to the stretching in the distal extrusion, the tip section was inverted inside the balloon.Further examination of the tip noted damage at the distal section.No other device issues were identified during returned product analysis.
 
Event Description
It was reported that there was slight resistance upon removal and device broke.The 70% stenosed target lesion was located in the mildly tortuous and moderately calcified middle left anterior descending artery.A 15mmx3.00mm wolverine coronary cutting balloon was selected for use.Upon withdrawal, there was slight resistance when attempting to remove the device.Then, the device broke upon a gentle subsequent attempt and the procedure was completed with another of the same device.No complications reported and patient was stable.
 
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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 Key18369506
MDR Text Key331323316
Report Number2124215-2023-71619
Device Sequence Number1
Product Code NWX
Combination Product (y/n)N
Reporter Country CodeTW
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 02/26/2024
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 Number3852
Device Catalogue Number3852
Device Lot Number0031728411
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/01/2023
Initial Date FDA Received12/20/2023
Supplement Dates Manufacturer Received02/08/2024
Supplement Dates FDA Received02/26/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/31/2023
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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