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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 02/24/2023
Event Type  malfunction  
Event Description
It was reported that a foreign material was found on the device.A 035/260 amplatz super stiff guidewire was selected for use.However, during preparation, a foreign matter was found in individual product bag.The procedure was completed with another of the same device.There were no patient complications reported.
 
Event Description
It was reported that a foreign material was found on the device.A 035/260 amplatz super stiff guidewire was selected for use.However, during preparation, a foreign matter was found in individual product bag.The procedure was completed with another of the same device.There were no patient complications reported.
 
Manufacturer Narrative
The device was inspected according to procedure.The device returned inside the pouch, and it was observed that the pouch information matches with the complaint information.The pouch was closed, and no open section was identified, however, a foreign matter was observed inside the package.There are none visual defects, contamination or damages observed on the pouch.The foreign matter was measured with the size estimation chart.According to the procedure, the foreign matter does not exceed the maximum size allowed.
 
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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
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
302 parkway, global park
la aurora - heredia
CS  
Manufacturer Contact
jeff wallner
4100 hamline ave n
arden hills, MN 55112
6515811560
MDR Report Key16577164
MDR Text Key311683249
Report Number2124215-2023-09787
Device Sequence Number1
Product Code DQX
UDI-Device Identifier08714729115830
UDI-Public08714729115830
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K843016
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 05/02/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/20/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number39575
Device Catalogue Number39575
Device Lot Number0030728056
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/05/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/16/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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