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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 Defective Device (2588)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/24/2023
Event Type  malfunction  
Event Description
It was reported that the markerband moved from the original position.An accustick ii was selected for use.During preparation, it was noted that the device ro marker was not in the original position.The procedure was completed with a different device.There were no patient complications.
 
Event Description
It was reported that the markerband moved from the original position.An accustick ii was selected for use.During preparation, it was noted that the device ro marker was not in the original position.The procedure was completed with a different device.There were no patient complications.
 
Manufacturer Narrative
Media analysis: the complaint device was not returned by the customer; nevertheless, physician has provided two photos of two device.As per pictures provided, it can be observed that the ro marker was out of its location in the device distal section and the accustick device was observed bent.No more damages were observed.Updated fields: evaluation method codes, evaluation result codes, evaluation result codes.
 
Manufacturer Narrative
Media analysis: the complaint device was not returned by the customer; nevertheless, physician has provided two photos of two device.As per pictures provided, it can be observed that the ro marker was out of its location in the device distal section and the accustick device was observed bent.No more damages were observed.Updated fields: evaluation method codes, evaluation result codes, evaluation result codes device evaluated by manufacturer: the device was returned for analysis.The accustick device was returned with the dilator and the canula.It was observed that the ro marker was out of its location in the device distal section since it moves freely.Additionally, the accustick device was bent and had the distal tip was broken.The canula was observed bent.The pouch was returned, and it was observed that the pouch information matches with the complaint information.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's 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 7,1 cm from the distal tip.
 
Event Description
It was reported that the markerband moved from the original position.An accustick ii was selected for use.During preparation, it was noted that the device ro marker was not in the original position.The procedure was completed with a different device.There were no patient complications.The complaint device was not returned by the customer; nevertheless, physician has provided two photos of two device.As per pictures provided, it can be observed that the ro marker was out of its location in the device distal section and the accustick device was observed bent.No more damages were observed.
 
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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 Key17142620
MDR Text Key317303813
Report Number2124215-2023-28358
Device Sequence Number1
Product Code KGZ
UDI-Device Identifier08714729201137
UDI-Public08714729201137
Combination Product (y/n)N
Reporter Country CodeMY
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 08/10/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/16/2023
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 Number0030457679
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/20/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/01/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age76 YR
Patient SexFemale
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