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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 Detachment of Device or Device Component (2907)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 05/12/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Age at time of event: (b)(6) years or older.Initial reporter facility name: (b)(6).
 
Event or Problem Description
It was reported that guidewire detachment occurred.A 0.014/190cm transcend guidewire was selected for use.However, during unpacking, the guidewire was detached.The procedure was completed with another of same device.No patient complications were reported.
 
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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 Key12084824
Report Number2134265-2021-08071
Device Sequence Number3870113
Product Code DQX
UDI-Device Identifier08714729326243
UDI-Public08714729326243
Combination Product (Y/N)N
Initial Reporter CountryCH
PMA/510(K) Number
K941710
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,distri
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 06/29/2021
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 Date10/06/2022
Device Model Number81735
Device Catalogue Number81735
Device Lot Number0026141841
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 06/09/2021
Initial Report FDA Received Date06/29/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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