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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 Problem Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/08/2024
Event Type  malfunction  
Event Description
It was reported that the distal tip of the wire delaminated.A v-18 control wire and sterling balloon catheter were selected for use in an arterial angioplasty procedure.During the procedure, the distal tip of the v-18 control wire became delaminated.
 
Event Description
It was reported that the distal tip of the wire delaminated.A v-18 control wire and sterling balloon catheter were selected for use in an arterial angioplasty procedure.During the procedure, the distal tip of the v-18 control wire became delaminated.
 
Manufacturer Narrative
Device eval by mfr: the device was returned, and analysis completed.Visual inspection of the returned device revealed that the ptfe coating had peeled.Inspection of the remainder of the device revealed no other damage or irregularities.
 
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Brand Name
V-18 CONTROL WIRE
Type of Device
WIRE, GUIDE, CATHETER
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
302 parkway, global park
la aurora - heredia
CS  
Manufacturer Contact
rachel shields
4100 hamline ave n
arden hills, MN 55112
6512422111
MDR Report Key18650774
MDR Text Key334805396
Report Number2124215-2024-05705
Device Sequence Number1
Product Code DQX
UDI-Device Identifier08714729070207
UDI-Public08714729070207
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K033742
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 04/12/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/06/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number40495
Device Catalogue Number40495
Device Lot Number0032001053
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/21/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/12/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
STERLING OTW BALLOON; STERLING OTW BALLOON
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