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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMPLATZ SUPER STIFF; WIRE, GUIDE, CATHETER
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BOSTON SCIENTIFIC CORPORATION AMPLATZ SUPER STIFF; WIRE, GUIDE, CATHETER Back to Search Results
Model Number 39695
Medical Device Problem Codes Unraveled Material (1664); Material Integrity Problem (2978)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 05/01/2021
Type of Reportable Event Malfunction
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 the guide wire coating peeled off.A 75cm.0 amplatz super stiff guidewire was selected for use; however, the coating was coming off and the spring coil was unravelling.No patient complications were reported.
 
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Brand Name
AMPLATZ SUPER STIFF
Common Device Name
WIRE, GUIDE, CATHETER
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key11922813
Report Number2134265-2021-06863
Device Sequence Number847875
Product Code DQX
UDI-Device Identifier08714729295754
UDI-Public08714729295754
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
K843017
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 06/02/2021
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 Date01/04/2024
Device Model Number39695
Device Catalogue Number39695
Device Lot Number0026579165
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 05/13/2021
Initial Report FDA Received Date06/02/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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