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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ACCUSTICK II; INTRODUCER, CATHETER
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BOSTON SCIENTIFIC CORPORATION ACCUSTICK II; INTRODUCER, CATHETER Back to Search Results
Model Number 35615
Device Problem Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/06/2021
Event Type  malfunction  
Manufacturer Narrative
Patient identifier: (b)(6).Age at time of event: 18 years or older.
 
Event Description
It was reported that the marker was not visible.An accustick ii was selected for use.During the procedure, it was noted that the distal radiopaque marker was not visible on imaging.The device was removed and checked under imaging externally, it was identified that the marker was located in the middle of the needle shaft rather at the distal tip.The procedure was completed with another of the same device.No patient complications reported.
 
Manufacturer Narrative
A1.Patient identifier: mrn: (b)(6).A2.Age at time of event: 18 years or older.Device evaluated by manufacturer: the device was returned for analysis.Visual inspection revealed the ro marker was in the device middle section.The device was inspected under microscope and rag marks were observed along the device.These marks are located in the space between the correct ro marker position and the current position.It is important to mention that evidence of correct ro marker colocation was observed at device distal end section.The device was measured in order to confirm the correct ro marker position and it was in wrong position.
 
Event Description
It was reported that the marker was not visible.An accustick ii was selected for use.During the procedure, it was noted that the distal radiopaque marker was not visible on imaging.The device was removed and checked under imaging externally, it was identified that the marker was located in the middle of the needle shaft rather at the distal tip.The procedure was completed with another of the same device.No patient complications reported.It was further reported that there was no visual issue/damage noted on the device prior to use.The procedure was completed using a replacement device and the patient was fine post procedure.
 
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Brand Name
ACCUSTICK II
Type of Device
INTRODUCER, CATHETER
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key12543921
MDR Text Key273758607
Report Number2134265-2021-12124
Device Sequence Number1
Product Code KGZ
UDI-Device Identifier08714729157588
UDI-Public08714729157588
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 10/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/28/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/18/2024
Device Model Number35615
Device Catalogue Number35615
Device Lot Number0026999039
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/12/2021
Date Manufacturer Received10/04/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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