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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WOLVERINE CORONARY CUTTING BALLOON; CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING
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BOSTON SCIENTIFIC CORPORATION WOLVERINE CORONARY CUTTING BALLOON; CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING Back to Search Results
Model Number 3855
Device Problems Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Patient Problem Foreign Body In Patient (2687)
Event Date 12/01/2022
Event Type  Injury  
Event Description
It was reported that removal difficulty and device detachment occurred.The target lesion was located in the left leg.A 15mmx2.50mm wolverine coronary cutting balloon was selected for use.During the procedure, the physician was doing a peripheral angiogram and inflated the balloon in the vessel more than once.When the physician tried to move the wolverine back, there was some resistance.The catheter got caught in the vessel and broke.Upon removal, part of the device remained in the peripheral.The peripheral was not limited in blood flow nor did the patient need any extra surgical intervention.
 
Manufacturer Narrative
Date of event: date of event was approximated to (b)(6) 2022 as no event date was reported.
 
Event Description
It was reported that removal difficulty and device detachment occurred.The target lesion was located in the left leg.A 15mmx2.50mm wolverine coronary cutting balloon was selected for use.During the procedure, the physician was doing a peripheral angiogram and inflated the balloon in the vessel more than once.When the physician tried to move the wolverine back, there was some resistance.The catheter got caught in the vessel and broke.Upon removal, part of the device remained in the peripheral.The peripheral was not limited in blood flow nor did the patient need any extra surgical intervention.
 
Manufacturer Narrative
B3 date of event: date of event was approximated to 12/01/2022 as no event date was reported.An incomplete device was returned for analysis.A visual and microscopic examination of the balloon identified a complete circumferential tear in the balloon material.The tear was located at 1.5cm distal from the proximal edge of the proximal balloon sleeve.A break was confirmed in the inner shaft and the distal section of the balloon including blades, a section of inner, and the tip were not returned for analysis.An examination of the balloon section could not identify any issues which could have resulted in this tear.A visual, microscopic and tactile examination found no damage along the hypotube.An examination of the distal extrusion identified that the extrusion was stretched.A kink was confirmed in the midshaft located at 3.5cm distal from the proximal edge of the midshaft.The inner shaft was severely stretched.There was a break in the inner located at 3.6cm distal from the proximal edge of the proximal balloon sleeve.As a result of the inner being severely stretched, the proximal markerband was positioned in the proximal transition zone in the balloon.The markerband was fully bonded to the inner.
 
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Brand Name
WOLVERINE CORONARY CUTTING BALLOON
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 CORPORATION
ballybrit business park
galway
EI  
Manufacturer Contact
jay johnson
4100 hamline ave n
arden hills, MN 55112
6515810888
MDR Report Key16195133
MDR Text Key307590845
Report Number2124215-2022-55779
Device Sequence Number1
Product Code NWX
UDI-Device Identifier08714729888338
UDI-Public08714729888338
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P950020
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/03/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/18/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/08/2024
Device Model Number3855
Device Catalogue Number3855
Device Lot Number0029008657
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/31/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/09/2022
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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