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	02/22/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via medwatch mw5084800 that the wire broke off and was snared from the patient.A.038 j-tip wire accustick ii was used in a left percutaneous nephrolithotomy placement procedure.During procedure, the wire of the accustik ii broke off inside the patient.The wire was then retrieved using a snare and no additional monitoring needed.No further patient complications reported.
Event or Problem Description
It was reported via medwatch mw5084800 that the wire broke off and was snared from the patinet.A.038 j-tip wire accustick ii was used in a left percutaneous nephrolithotomy placement procedure.During procedure, the wire of the accustik ii broke off inside the patient.The wire was then retrieved using a snare and no additional monitoring needed.No further patient complications reported.It was further reported that there were no device fragments left in the patient's body and the patient was stable.

• 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: 8487332
• Report Number: 2134265-2019-03505
• Device Sequence Number: 19303968
• Product Code: KGZ
• UDI-Device Identifier: 08714729157588
• UDI-Public: 08714729157588
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K952828
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/13/2021
• Device Model Number: 35615
• Device Catalogue Number: 35615
• Device Lot Number: 0022113502
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/13/2019
• Supplement Date Received by Manufacturer: 04/08/2019
• Initial Report FDA Received Date: 04/05/2019
• Supplement Report FDA Received Date: 04/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention