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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 Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919); Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/09/2023
Event Type  malfunction  
Event Description
It was reported that markerband malposition occurred.Two accustick ii kits were selected for use in the kidney for nephrostomy drain placement.During the procedure, the physician had difficulty advancing the sheaths on the accusticks and it was noted that the ro markers would slide up the sheath impairing his vision.When the device was advanced through the skin, the marker stayed at the skin as the device advanced into the patient.It happened with two devices in a row.The skin incision was appropriate.The physician commented that he had never seen the marker slide down.The sheaths were also noted to be kinked at the distal tip of the device.The devices were pulled out intact from the patient's body and the procedure was completed with this device.No patient complications were reported.
 
Manufacturer Narrative
Device evaluated by mfr: the complaint device was received for product analysis.The accustick device was returned, and it was observed that the ro marker was out of its location in the device middle section since it moves freely.Additionally, the accustick device was bent at ro marker actual location and had the distal tip was broken.No more damages were observed.The device was inspected under microscope, and it was observed that the distal tip was broken, this damage is located next to the ro marker 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 ro marker position; and the ro marker was located approximately at 9.5cm from the distal tip and does not meet specification.The od (outer diameter) of the ro marker could not be measured due the accustick device was bent at ro marker actual location.No other issues were identified during the product analysis.
 
Event Description
It was reported that markerband malposition occurred.Two accustick ii kits were selected for use in the kidney for nephrostomy drain placement.During the procedure, the physician had difficulty advancing the sheaths on the accusticks and it was noted that the ro markers would slide up the sheath impairing his vision.When the device was advanced through the skin, the marker stayed at the skin as the device advanced into the patient.It happened with two devices in a row.The skin incision was appropriate.The physician commented that he had never seen the marker slide down.The sheaths were also noted to be kinked at the distal tip of the device.The devices were pulled out intact from the patient's body and the procedure was completed with this device.No patient complications were reported.
 
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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
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
780 brookside drive
spencer IN 47460
Manufacturer Contact
jay johnson
4100 hamline ave n
arden hills, MN 55112
6515810888
MDR Report Key16484908
MDR Text Key310687380
Report Number2124215-2023-09514
Device Sequence Number1
Product Code KGZ
UDI-Device Identifier08714729201137
UDI-Public08714729201137
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
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 03/28/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/06/2023
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 Number0030776020
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/07/2023
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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