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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
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/16/2018
Event Type  malfunction  
Event Description
It was reported that guide wire detachment occurred.A 75cm amplatz - pi guide wire was selected for used to crossed the lesion; however, it was noted that the wire broke.No patient complications were reported.
 
Manufacturer Narrative
Device evaluated by mfr.: the unit returned has tip unraveled, as part of overall visual revision.The device is not broken even thought it has its distal tip severely kink and stretch.The body is all bent.Distal tip, middle of the device and proximal section were within specifications.
 
Event Description
It was reported that guide wire detachment occurred.A 75cm amplatz - pi guide wire was selected for used to crossed the lesion; however, it was noted that the wire broke.No patient complications were reported.
 
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Brand Name
AMPLATZ SUPER STIFF
Type of Device
WIRE, GUIDE, CATHETER
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key8180146
MDR Text Key130886695
Report Number2134265-2018-64515
Device Sequence Number1
Product Code DQX
Combination Product (y/n)N
PMA/PMN Number
K843017
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 02/13/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/19/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/08/2021
Device Model Number39695
Device Catalogue Number39695
Device Lot Number0022493269
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/27/2018
Date Manufacturer Received01/21/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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