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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PT GRAPHIX; WIRE, GUIDE, CATHETER
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BOSTON SCIENTIFIC CORPORATION PT GRAPHIX; WIRE, GUIDE, CATHETER Back to Search Results
Model Number 2560
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 05/17/2019
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported via user/facility medwatch# (b)(4) that guide wire tip detachment occurred.The target lesion was located in the distal left pedal artery.A 300cm choice pt graphix intermediate guide wire was advanced to cross the lesion.However, upon attempting to remove the guide wire after balloon inflation, the tip broke off approximately 0.5cm.The detached tip was unable to retrieve.The procedure ended leaving the tip in place and no further patient complications were reported.
 
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Brand Name
PT GRAPHIX
Common Device Name
WIRE, GUIDE, CATHETER
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key8708020
Report Number2134265-2019-07067
Device Sequence Number19429925
Product Code DQX
UDI-Device Identifier08714729141969
UDI-Public08714729141969
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
K143587
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Risk Manager
Type of Report Initial
Report Date (Section B) 06/18/2019
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 Date11/16/2019
Device Model Number2560
Device Catalogue Number2560
Device Lot Number0021399812
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/11/2019
Initial Report FDA Received Date06/18/2019
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 Other;
Patient Age84 YR
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