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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 Problems Defective Device (2588); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/12/2023
Event Type  malfunction  
Event Description
It was reported that the markerband was dislodged.The target lesion was located in the kidney.An accustick ii w/o guidewire was selected for use.After withdrawing the device from the patient, it was noted that the silver markerband was found in the upper part of the dilator and not at the end of the introducer.The procedure was completed with this device.No complications were reported.
 
Manufacturer Narrative
Device evaluated by mfr.: the device was returned for analysis.Overall visual revision did not identify failures or evidence that could be lost due to decontamination process.Media inspection of a picture attached, and the reported error is not shown in the photo.Visual inspection of the accustick device was returned with the sheath, dilator and the canula stuck inside the device.It was observed that the ro marker was out of its location due it was separated from the accustick device.Additionally, the accustick device was damage at distal tip.No more damages were observed.The device was inspected under microscope, and it was observed that the distal tip was damage, this damage is located next to the ro marker position.
 
Event Description
It was reported that the markerband was dislodged.The target lesion was located in the kidney.An accustick ii w/o guidewire was selected for use.After withdrawing the device from the patient, it was noted that the silver markerband was found in the upper part of the dilator and not at the end of the introducer.The procedure was completed with this device.No complications were reported.
 
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Brand Name
ACCUSTICK II
Type of Device
INTRODUCER, CATHETER
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
780 brookside drive
spencer IN 47460
Manufacturer Contact
rachel shields
4100 hamline ave n
arden hills, MN 55112
6512422111
MDR Report Key18438597
MDR Text Key331904514
Report Number2124215-2023-74573
Device Sequence Number1
Product Code KGZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 02/22/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/03/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number35615
Device Catalogue Number35615
Device Lot Number0030775916
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/06/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/03/2023
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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