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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CHOICE; WIRE, GUIDE, CATHETER
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BOSTON SCIENTIFIC CORPORATION CHOICE; WIRE, GUIDE, CATHETER Back to Search Results
Model Number 1960
Medical Device Problem Code Material Integrity Problem (2978)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 09/25/2018
Type of Reportable Event Malfunction
Event or Problem Description
It was reported via voluntary medwatch # mw5080210 that guide wire coating peeled off.The target lesion was located in the right coronary artery.After a guide catheter was placed in the lesion, a 182cm choice guide wire was advanced to cross the lesion.However, the wire ended up going through one of the side holes and when it was retracted, a piece of the wire coating came off.The wire and guide catheter were removed as one unit from the patient.No patient complications were reported.
 
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Brand Name
CHOICE
Common Device Name
WIRE, GUIDE, CATHETER
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key8065352
Report Number2134265-2018-62801
Device Sequence Number2141507
Product Code DQX
UDI-Device Identifier08714729150572
UDI-Public08714729150572
Combination Product (Y/N)N
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 Nurse
Type of Report Initial
Report Date (Section B) 11/13/2018
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 Date06/22/2020
Device Model Number1960
Device Catalogue Number1960
Device Lot Number0022292044
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/22/2018
Initial Report FDA Received Date11/13/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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