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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION V-18 CONTROL WIRE; WIRE, GUIDE, CATHETER
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BOSTON SCIENTIFIC CORPORATION V-18 CONTROL WIRE; WIRE, GUIDE, CATHETER Back to Search Results
Model Number 40495
Device Problems Difficult to Advance (2920); Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/17/2023
Event Type  malfunction  
Manufacturer Narrative
Initial reporter address 1: (b)(6).
 
Event Description
It was reported that foreign matter was present on the device.The 99% stenosed target lesion was located in the moderately tortuous and moderately calcified shunt vessel.A 200cm, 8cm poly tip v-18 control wire was selected for use together with a non-boston scientific (bsc) balloon catheter.However, a significant resistance was felt when the tip of the wire crossed the stent in front of the central lesion.An echocardiogram confirmed that it probably did not pass through the stent strut.It has been a while since the stent was placed, so the intima should be stretched.After the guide wire did not advance in the body and the torque was no longer effective, it was taken out of the body and the guide wire was advanced and pulled in the guide wire lumen of the balloon to check the condition, and a foreign object that was about 1 cm black that is thinner than the guide wire came out.According to the physician, the damage to the guidewire was not visually confirmed.The foreign matter seemed to be part of the guide wire.The procedure was completed with another of the same device.There were no patient complications reported.
 
Event Description
It was reported that foreign matter was present on the device.The 99% stenosed target lesion was located in the moderately tortuous and moderately calcified shunt vessel.A 200cm, 8cm poly tip v-18 control wire was selected for use together with a non-boston scientific (bsc) balloon catheter.However, a significant resistance was felt when the tip of the wire crossed the stent in front of the central lesion.An echocardiogram confirmed that it probably did not pass through the stent strut.It has been a while since the stent was placed, so the intima should be stretched.After the guide wire did not advance in the body and the torque was no longer effective, it was taken out of the body and the guide wire was advanced and pulled in the guide wire lumen of the balloon to check the condition, and a foreign object that was about 1 cm black that is thinner than the guide wire came out.According to the physician, the damage to the guidewire was not visually confirmed.The foreign matter seemed to be part of the guide wire.The procedure was completed with another of the same device.There were no patient complications reported.
 
Manufacturer Narrative
E1: initial reporter address 1: (b)(6).Device evaluated by mfr.: the device was returned, and it was observed the distal tip was bent.No more issues or damages were observed.The device outer diameter was dimensionally inspected and found to be within specification.
 
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Brand Name
V-18 CONTROL WIRE
Type of Device
WIRE, GUIDE, CATHETER
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
302 parkway, global park
la aurora - heredia
CS  
Manufacturer Contact
jay johnson
4100 hamline ave n
arden hills, MN 55112
6515810888
MDR Report Key16308618
MDR Text Key308946586
Report Number2124215-2023-02696
Device Sequence Number1
Product Code DQX
UDI-Device Identifier08714729070191
UDI-Public08714729070191
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K033742
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 03/15/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/06/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/16/2024
Device Model Number40495
Device Catalogue Number40495
Device Lot Number0028884536
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/24/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/16/2022
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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