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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 07/24/2023
Event Type  malfunction  
Event Description
It was reported that the balloon got stuck with the guidewire.A 10mmx3.00mm wolverine coronary cutting balloon was selected for percutaneous transluminal coronary angioplasty (ptca).During the procedure, when the physician tried to advance the balloon on the guidewire, the balloon got stuck on the wire and the physician could not advance the balloon.The balloon was removed normally without any further intervention and the procedure was completed with a different device.No complications were reported, and the patient was stable after the procedure.
 
Manufacturer Narrative
E1 - initial reporter address 1: (b)(6).
 
Event Description
It was reported that the balloon got stuck with the guidewire.A 10mmx3.00mm wolverine coronary cutting balloon was selected for percutaneous transluminal coronary angioplasty (ptca).During the procedure, when the physician tried to advance the balloon on the guidewire, the balloon got stuck on the wire and the physician could not advance the balloon.The balloon was removed normally without any further intervention and the procedure was completed with a different device.No complications were reported, and the patient was stable after the procedure.
 
Manufacturer Narrative
E1 - initial reporter address 1: (b)(6).Device evaluated by mfr: the complaint device was received for product analysis.A visual and tactile examination of the hypotube shaft identified no damages.A visual examination of the distal extrusion identified that the distal extrusion was severely bunched and accordioned at the balloon area.Microscopic examination of the distal extrusion, including the inner/wire lumen, identified that the extrusion was stretched, bunched and accordioned.This damage was located just proximal from the distal tip end it extended proximally for approximately 4.4cm in length.The inner/wire lumen inside the balloon was severely bunched.A detailed microscopic examination of the balloon identified that the proximal sleeve of the balloon was inverted, inside the balloon.All blades were fully bonded on the balloon and did not exhibit any signs of damage.A microscopic examination of the tip found that the distal edge of the tip was flared.A device-to-device interaction test was performed, and it was not possible to load a recommended 0.014-inch size wire through the wire lumen due to the severe bunching in the distal extrusion.No other issues were identified during the product analysis.
 
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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 Key17585730
MDR Text Key321626644
Report Number2124215-2023-43067
Device Sequence Number1
Product Code NWX
Combination Product (y/n)N
Reporter Country CodeIN
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 12/19/2023
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 Model Number3851
Device Catalogue Number3851
Device Lot Number0030639288
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/31/2023
Initial Date FDA Received08/21/2023
Supplement Dates Manufacturer Received12/06/2023
Supplement Dates FDA Received12/19/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/02/2022
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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