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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 2777
Medical Device Problem Code Detachment of Device or Device Component (2907)
Health Effect - Clinical Code Device Embedded In Tissue or Plaque (3165)
Date of Event 02/04/2020
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that tip detachment occurred.The target lesion was located in a coronary artery.A 185cm pt2 guidewire was selected for use.The physician was able to place the balloon and stent however, during removal, approximately 8-10mm segment of the distal tip of the wire remained in the patient's coronary artery.The end of the wire was retained in the patient's body and was not retrieved.The procedure was completed and there were no patient complications reported.
 
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Brand Name
PT
Common Device Name
WIRE, GUIDE, CATHETER
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key9738983
Report Number2134265-2020-01830
Device Sequence Number1815702
Product Code DQX
UDI-Device Identifier08714729471196
UDI-Public08714729471196
Combination Product (Y/N)N
Initial Reporter StateVA
Initial Reporter CountryUS
PMA/510(K) Number
K030617
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 02/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date11/10/2021
Device Model Number2777
Device Catalogue Number2777
Device Lot Number0024752400
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 02/04/2020
Initial Report FDA Received Date02/21/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age62 YR
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