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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 2781
Medical Device Problem Code Fracture (1260)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 11/01/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Date of event: used the first date of the month of the aware date as no event date was provided.
 
Event or Problem Description
It was reported that guide wire fracture occurred.Two 300 cm light support straight tip pt wires were used in a percutaneous transluminal angioplasty.However, the first wire broke and was removed with the help of a balloon.The second wire also broke, but required a superficial femoral surgery.The procedure was completed with another of same device.No further patient complications were reported.
 
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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 Key8146765
Report Number2134265-2018-63761
Device Sequence Number16581353
Product Code DQX
UDI-Device Identifier08714729471158
UDI-Public08714729471158
Combination Product (Y/N)N
Initial Reporter CountryIT
PMA/510(K) Number
K030617
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 12/10/2018
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 Date07/03/2020
Device Model Number2781
Device Catalogue Number2781
Device Lot Number0022336913
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/15/2018
Initial Report FDA Received Date12/10/2018
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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