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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 05/28/2020
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 right coronary artery (rca).A 182cm j choice pt graphix standard guidewire was advanced for use.However, during procedure, the tip of the guidewire was fractured.The detached tip could not be retrieved with a snare.An unknown drug-eluting stent was used to affix and appose the detached tip in place in the rca.No further complications were reported and the patient's status was 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 Key10133993
Report Number2134265-2020-07664
Device Sequence Number11716299
Product Code DQX
UDI-Device Identifier08714729141754
UDI-Public08714729141754
Combination Product (Y/N)N
Initial Reporter StateRI
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) 06/09/2020
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 05/29/2020
Initial Report FDA Received Date06/09/2020
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;
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