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	02/18/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the radiopaque marker was not in the position.An accustick ll catheter was selected for use for a percutaneous transhepatic biliary drainage procedure.During preparation, it was found out that the radiopaque marker was marked only in the proximal portion of the catheter, when it is normally marked on the distal section.The procedure was completed with another of the same device.No complications reported.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.One accustick device was returned for analysis (cannula, dilator, sheath, introducer needle and stylet.).No visual damages were observed with the cannula, dilator, introducer needle and stylet.Residues in the distal section of the dilator indicates use and handling of the device.The tip of the sheath is damaged and the ro marker has been pushed proximally approximately 3.5 cm toward the hub.Marker impression on the sheath surface indicates the ro marker had been properly assembled and swaged onto the distal end.
Event or Problem Description
It was reported that the radiopaque marker was not in the position.An accustick ll catheter was selected for use for a percutaneous transhepatic biliary drainage procedure.During preparation, it was found out that the radiopaque marker was marked only in the proximal portion of the catheter, when it is normally marked on the distal section.The procedure was completed with another of the same device.No complications reported.

• 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: 8413218
• Report Number: 2134265-2019-02355
• Device Sequence Number: 11305408
• Product Code: KGZ
• UDI-Device Identifier: 08714729157625
• UDI-Public: 08714729157625
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K952828
• 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): 04/11/2019

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: 11/06/2021
• Device Model Number: 35615
• Device Catalogue Number: 35615
• Device Lot Number: 22902800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2019
• Initial Date Received by Manufacturer: 02/18/2019
• Supplement Date Received by Manufacturer: 03/21/2019
• Initial Report FDA Received Date: 03/12/2019
• Supplement Report FDA Received Date: 04/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1