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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AMPLATZ SUPER STIFF; WIRE, GUIDE, CATHETER
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AMPLATZ SUPER STIFF; WIRE, GUIDE, CATHETER Back to Search Results
Model Number 39575
Medical Device Problem Code Fracture (1260)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 10/04/2021
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that guidewire fracture occurred.The patient presented with claudication and underwent a left leg angiogram.The target lesion was located in a moderately tortuous and moderately calcified left iliac artery.After an s/s xch/035/180 amplatz super stiff guidewire was crossed the lesion.A 10.0 x 40 x 75cm express ld iliac / biliary stent was advanced for treatment.However, during the deployment of the stent, the entire device was crimped and the guidewire frayed.The physician then deployed an additional express ld iliac / biliary stent to cover it and the procedure was completed.No patient complications were reported.The patient's status was stable.
 
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Brand Name
AMPLATZ SUPER STIFF
Common Device Name
WIRE, GUIDE, CATHETER
MDR Report Key12703186
Report Number2134265-2021-12987
Device Sequence Number1467792
Product Code DQX
UDI-Device Identifier08714729295730
UDI-Public08714729295730
Combination Product (Y/N)N
Initial Reporter StateNY
Initial Reporter CountryUS
PMA/510(K) Number
K843013
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 Health Care Professional
Type of Report Initial
Report Date (Section B) 10/27/2021
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 Date06/22/2024
Device Model Number39575
Device Catalogue Number39575
Device Lot Number0027546502
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 10/04/2021
Initial Report FDA Received Date10/27/2021
Was Device Evaluated by Manufacturer? (Y/N) Device Not Returned to Manufacturer
Date Device Manufactured06/23/2021
Is the Device Labeled for Single Use? (Y/N) Yes
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device Initial
Patient Sequence Number1
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