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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 Problems Break (1069); Difficult to Remove (1528)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/02/2023
Event Type  malfunction  
Event Description
It was reported that the catheter was fractured.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified left circumflex artery.A 10mmx2.00mm wolverine coronary cutting balloon was selected for use.Upon withdrawal, the device was difficult to remove, and it was noted that the catheter was fractured.The procedure was completed with another of same device.No complications were reported, and patient was stable post procedure.
 
Manufacturer Narrative
E1: initial reporter facility name: (b)(6).
 
Event Description
It was reported that the catheter was fractured.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified left circumflex artery.A 10mmx2.00mm wolverine coronary cutting balloon was selected for use.Upon withdrawal, the device was difficult to remove, and it was noted that the catheter was fractured.The procedure was completed with another of same device.No complications were reported, and patient was stable post procedure.
 
Manufacturer Narrative
E1: initial reporter facility name: (b)(6) hospital.Device evaluated by manufacturer: the device was returned for analysis.A visual tactile, microscopic examination and device to device interaction testing was performed.The device was received in two sections as a result of a break in the hypotube.The break was located at 76.5cm distal to the distal end of the strain relief.A visual and tactile examination identified multiple kinking along both sections of the hypotube break.A visual and tactile examination identified no kinks or damages to the shaft polymer extrusion.A microscopic examination of the distal shaft polymer extrusion profile identified no damages.A detailed microscopic examination of the balloon material identified no damages.All blades were fully bonded on the balloon and did not exhibit any signs of damage.A microscopic examination of the tip section found no damage.The device-to-device interaction test revealed that it was possible to load a 0.014inch size guidewire through the tip and wire lumen.
 
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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 Key17193936
MDR Text Key317904437
Report Number2124215-2023-31116
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 Other,Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 08/30/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/23/2023
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 Number0030611772
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/11/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/28/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age70 YR
Patient SexFemale
Patient Weight63 KG
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