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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 2480
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 02/26/2020
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that guidewire tip detachment occurred.The target lesion was located in the left anterior descending artery.A 182cm j pt graphix guidewire was advanced to cross the lesion.However, during procedure, it was noted that the wire prolapsed on itself.Then the tip of the wire became disconnected and broke off inside the artery.Snaring was attempted but failed to retrieve the detached tip.Another wire was used and completed the procedure.No further patient complications were reported.The patient was fine and stable.
 
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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 Key9829902
Report Number2134265-2020-03166
Device Sequence Number16851550
Product Code DQX
UDI-Device Identifier08714729141754
UDI-Public08714729141754
Combination Product (Y/N)N
Initial Reporter StateFL
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 Physician
Type of Report Initial
Report Date (Section B) 03/13/2020
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 Date10/14/2021
Device Model Number2480
Device Catalogue Number2480
Device Lot Number0024602184
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 02/26/2020
Initial Report FDA Received Date03/13/2020
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 Age51 YR
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