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

Model Number	35615
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: approximated to (b)(6) 2021 based on the date boston scientific was made aware.
Event or Problem Description
It was reported that the device was broken and/or fractured.An accustick ii introducer catheter was selected for use in a drainage procedure.During preparation, the device was reported to break and/or fracture.The procedure was completed using another accustick ii.No patient complications were reported.
Event or Problem Description
It was reported that the device was broken/fractured.An accustick ii introducer catheter was selected for use in a drainage procedure.During preparation, the device was reported to break and/or fracture.The procedure was completed using another accustick ii.No patient complications were reported.It was further reported that upon insertion, it was noticed that the tip below the marker had a tear or split in it.
Additional Manufacturer Narrative
B3: date of event: initially reported as approximated to 05/01/2021 based on the date boston scientific was made aware.Event date was confirmed to be 05/12/2021.

• 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: 11939921
• Report Number: 2134265-2021-07215
• Device Sequence Number: 4066360
• Product Code: KGZ
• UDI-Device Identifier: 08714729194514
• UDI-Public: 08714729194514
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2021

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: 10/01/2023
• Device Model Number: 35615
• Device Catalogue Number: 35615
• Device Lot Number: 0026111620
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/12/2021
• Supplement Date Received by Manufacturer: 06/09/2021
• Initial Report FDA Received Date: 06/04/2021
• Supplement Report FDA Received Date: 07/02/2021
• Patient Sequence Number: 1