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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 Material Integrity Problem (2978)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 02/28/2020
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that guide wire coating issue occurred.The target lesion was located in the right coronary artery.A 185cm moderate support straight pt guide wire was advanced to cross the lesion.However, it was observed that the outer coating got separated from the wire and formed a clump.The device was removed and no device fragment remained in the patient's body.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was fine.
 
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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 Key9835068
Report Number2134265-2020-03296
Device Sequence Number1299705
Product Code DQX
UDI-Device Identifier08714729471196
UDI-Public08714729471196
Combination Product (Y/N)N
Initial Reporter StateNV
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) 03/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date10/06/2021
Device Model Number2777
Device Catalogue Number2777
Device Lot Number0024556741
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 03/02/2020
Initial Report FDA Received Date03/16/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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