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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION TRANSEND; WIRE, GUIDE, CATHETER
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BOSTON SCIENTIFIC CORPORATION TRANSEND; WIRE, GUIDE, CATHETER Back to Search Results
Model Number 81735
Medical Device Problem Code Material Integrity Problem (2978)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 09/04/2019
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that guide wire coating was peeled off.The target lesion was located in the liver artery.A 135cm transcend guide wire was selected for use.However, during the procedure, as the physician was making the shape of the distal tip 3-4 times, it was noted that the coating of the distal tip was peeling.The procedure was completed with another of the same device.There were no patient complications nor injuries reported and the patient was stable.
 
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Brand Name
TRANSEND
Common Device Name
WIRE, GUIDE, CATHETER
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key9105968
Report Number2134265-2019-11480
Device Sequence Number16625410
Product Code DQX
UDI-Device Identifier08714729326274
UDI-Public08714729326274
Combination Product (Y/N)N
Initial Reporter CountryKS
PMA/510(K) Number
K941710
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,distri
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 09/23/2019
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 Date02/14/2021
Device Model Number81735
Device Catalogue Number81735
Device Lot Number0023356002
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/10/2019
Initial Report FDA Received Date09/23/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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