MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ACCUSTICK II; INTRODUCER, CATHETER

Model Number	35615
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/03/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a tip fracture occurred.The target lesion was located in the liver.An accustick ii was selected for use in a percutaneous transhepatic biliary drainage (ptbd).During preparation, it was noted that the tip was broken.The procedure was completed with another of the same device.No patient complications were reported.
Event or Problem Description
It was reported that a tip fracture occurred.The target lesion was located in the liver.An accustick ii was selected for use in a percutaneous transhepatic biliary drainage (ptbd).During preparation, it was noted that the tip was broken.The procedure was completed with another of the same device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.A visual inspection revealed that only accustick device was returned for analysis (cannula, dilator, sheath, introducer needle and stylet.).No visual issues were observed with the introducer needle and stylet.The devices did not have any broken section.Residues were observed over the dilator indicating use and handling of the device.The distal section of the cannula, dilator and sheath had a severe kink.The tip of the dilator was damaged.A functional inspection revealed that the components could not be taken apart due to severe kinking at distal section.

• Brand Name: ACCUSTICK II
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9711278
• Report Number: 2134265-2020-01545
• Device Sequence Number: 13541470
• Product Code: KGZ
• UDI-Device Identifier: 08714729157625
• UDI-Public: 08714729157625
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/11/2021
• Device Model Number: 35615
• Device Catalogue Number: 35615
• Device Lot Number: 0021847582
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2020
• Initial Date Received by Manufacturer: 02/03/2020
• Supplement Date Received by Manufacturer: 03/24/2020
• Initial Report FDA Received Date: 02/14/2020
• Supplement Report FDA Received Date: 03/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1