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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PT; WIRE, GUIDE, CATHETER
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BOSTON SCIENTIFIC CORPORATION PT; WIRE, GUIDE, CATHETER Back to Search Results
Model Number 2779
Device Problem Detachment of Device or Device Component (2907)
Patient Problem Foreign Body In Patient (2687)
Event Date 02/29/2024
Event Type  Injury  
Event Description
It was reported that tip detachment occurred.The target lesion was located in the anterior descending artery.A 185cm j-tip, pt2 guidewire was selected for use.A pt2 guidewire was recrossed through the stent struts, however; when the guidewire was removed, the tip remained inside the stent.The procedure was completed with this device.The patient status was stable.
 
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Brand Name
PT
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 Key18890548
MDR Text Key337509933
Report Number2124215-2024-13853
Device Sequence Number1
Product Code DQX
UDI-Device Identifier08714729471202
UDI-Public08714729471202
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
K030617
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
Report Date 03/12/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/12/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number2779
Device Catalogue Number2779
Device Lot Number0031940054
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/04/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/03/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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