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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 39575
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/26/2021
Event Type  malfunction  
Event Description
It was reported that foreign material was present on the device.The target lesion was located in moderately tortuous and mildly calcified aorta.A s/s st/035/145 (bx/1) amplatz super stiff guidewire was used.However.During insertion it was confirmed that the tip part of the device had black foreign material attached.The procedure was completed with another of same device.Thee were no patient complications nor injuries reported.
 
Event Description
It was reported that foreign material was present on the device.The target lesion was located in moderately tortuous and mildly calcified aorta.A s/s st/035/145 (bx/1) amplatz super stiff guidewire was used.However.During insertion it was confirmed that the tip part of the device had black foreign material attached.The procedure was completed with another of same device.Thee were no patient complications nor injuries reported.
 
Manufacturer Narrative
Device evaluated by mfr.: the unit returned has the tip kinked, as part of overall visual revision.The returned device matches with upn provided by the customer.The returned guidewire was unraveled, and the coiled wire was broken, also the distal end of the guidewire was kinked.No more visual damages were found in the device.The coiled wire was stretched and broken.The device was measured and met the specifications.
 
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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 Key11992004
MDR Text Key255975457
Report Number2134265-2021-07556
Device Sequence Number1
Product Code DQX
UDI-Device Identifier08714729295723
UDI-Public08714729295723
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,distri
Type of Report Initial,Followup
Report Date 07/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/14/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/22/2023
Device Model Number39575
Device Catalogue Number39575
Device Lot Number0026233480
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/07/2021
Date Manufacturer Received06/22/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
GUIDEWIRE USED: AMPLATZ; GUIDEWIRE USED: AMPLATZ; INTRODUCER SHEATH USED: TERUMO; INTRODUCER SHEATH USED: TERUMO; GUIDEWIRE USED: AMPLATZ.; INTRODUCER SHEATH USED: TERUMO.
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