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

Model Number	35615
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/16/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tip of the guidewire was split.An accustick ii guidewire was selected for use.During the procedure, it was noted that the end point of the wire was split due.The procedure was completed with another of the same device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: an accustick device was returned for analysis (dilator, sheath and molded stiffener).Visual inspection of the returned device showed residues on the dilator and stiffener that indicate use and handling of the device.No visual issues were observed with the molded stiffener.The tip of the sheath and dilator were damaged (bent outwards), also drag marks observed on shaft of the sheath indicate that the radiopaque (ro) marker was moved proximally indicating the device was pushed against a hard surface.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that the tip of the guidewire was split.An accustick ii guidewire was selected for use.During the procedure, it was noted that the end point of the wire was split.The procedure was completed with another of the same device.No patient complications were 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: 8173675
• Report Number: 2134265-2018-64413
• Device Sequence Number: 13817948
• Product Code: KGZ
• UDI-Device Identifier: 08714729157625
• UDI-Public: 08714729157625
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 05/13/2020

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: 06/24/2021
• Device Model Number: 35615
• Device Catalogue Number: 35615
• Device Lot Number: 0022294314
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2020
• Initial Date Received by Manufacturer: 11/19/2018
• Supplement Date Received by Manufacturer: 04/30/2020
• Initial Report FDA Received Date: 12/18/2018
• Supplement Report FDA Received Date: 05/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1