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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 Difficult to Remove (1528); Difficult to Advance (2920); Material Integrity Problem (2978)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/17/2019
Event Type  malfunction  
Manufacturer Narrative
Age at time of event: 18 years or older a visual and microscopic examination was performed on the returned device.The device was returned in two separate sections, with the distal section still loaded onto an unknown 0.014 inch guidewire.A visual and tactile examination identified a complete break in the shaft polymer extrusion approximately 1460mm distal to the strain relief.Severe stretching and kinking damage was also noted on the shaft polymer extrusion.Due to this severe damage the customer's guidewire could not be removed from the wolverine device.This type of damage is consistent with excessive force being applied to the delivery system.A visual examination identified that the balloon material was severely bunched up.This type of damage is consistent with excessive force being applied to the delivery system.A visual and microscopic examination of the balloon material did not identify any tears in the material.The markerbands and blades of the device were visually and microscopically examined and no issues were noted with the device that may have potentially contributed to the complaint incident.All blades were present and fully bonded to the balloon material.A visual and microscopic examination of the tip identified severe kinking and stretching damage.This type of damage is consistent with excessive force being applied to the delivery system.A visual and tactile examination identified multiple kinks on the hypotube of the device.This type of damage is consistent with excessive force being applied to the delivery system.
 
Event Description
Reportable based on the product analysis completed on (b)(6) 2019.It was reported that insertion and withdrawal difficulty occurred.A percutaneous coronary intervention was being performed on a 75% stenosed, moderately calcified and moderately tortuous lesion in the mid right coronary artery.The 10mmx3.00mm wolverine coronary cutting balloon was used successfully once.After removal, the physician tried to advance it again, but there was severe resistance.When the balloon was advanced into the proximal y-connector, it was unable to cross and the balloon was difficult to remove.After applying force, the balloon was removed, however, the balloon was noted to be damaged/crushed.The procedure was successfully completed with a different device without issue or patient injury.However, the returned product analysis revealed that a shaft break occurred.
 
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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
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC IRELAND LIMITED
ballybrit business park
galway
EI  
Manufacturer Contact
sonali arangil
two scimed place
maple grove, MN 55311
6515827403
MDR Report Key8412276
MDR Text Key138528388
Report Number2134265-2019-02061
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 company representative,distri
Reporter Occupation Physician
Type of Report Initial
Report Date 03/12/2019
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 Expiration Date11/07/2020
Device Model Number3851
Device Catalogue Number3851
Device Lot Number0022912241
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/28/2019
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/27/2019
Initial Date FDA Received03/12/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/08/2018
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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