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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 Contamination (1120); Defective Device (2588)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/26/2023
Event Type  malfunction  
Manufacturer Narrative
E1 - initial reporter address 1: (b)(6).
 
Event Description
It was reported that device contamination occurred.A 10mmx2.25mm wolverine coronary cutting balloon was selected for percutaneous coronary intervention (pci).During withdrawal, it was noted that there was something pointy near the exit port of the device and the gloves were damaged.Upon further checking, it was a piece of plastic that seemed to have come off when the glove was damaged.The procedure was completed using this device.There was no damage to the human body and no health problems.
 
Manufacturer Narrative
E1 - initial reporter address 1: (b)(6).Device evaluated by mfr: the complaint device was received for analysis along with a latex glove and some gauze.A visual and tactile examination of the hypotube shaft profile identified no kinks or damages.A visual and tactile examination of the distal extrusion identified no damages.A detailed microscopic examination of the balloon material identified no damages.The balloon was not tightly folded and did not exhibit any signs of device use.All blades were fully bonded on the balloon and did not exhibit any signs of damage.A microscopic examination of the guidewire exit port and entire distal extrusion, did not identify any damages.A microscopic examination of the tip section found no damages.A finger section in the glove was marked out with arrows in blank ink.A detailed microscopic examination of this section of glove identified no tears or damages to the glove.A visual and microscopic examination of the gauze did not find any foreign material attached to the gauze.A recommended 0.014 inch size wire was inserted through the tip and wire lumen with no resistance noted.The guidewire exited out through the guidewire exit port with no resistance noted.No other issues were identified during the product analysis.
 
Event Description
It was reported that device contamination occurred.A 10mmx2.25mm wolverine coronary cutting balloon was selected for percutaneous coronary intervention (pci).During withdrawal, it was noted that there was something pointy near the exit port of the device and the gloves were damaged.Upon further checking, it was a piece of plastic that seemed to have come off when the glove was damaged.The procedure was completed using this device.There was no damage to the human body and no health problems.
 
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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 Key17579440
MDR Text Key321513193
Report Number2124215-2023-41790
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 10/16/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/18/2023
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 Number0031270107
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/21/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/21/2023
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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