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

Model Number 35615

Device Problem Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/12/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: approximated to (b)(6) 2021 based on the date boston scientific was made aware.

Event 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 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.

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
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11939921
• MDR Text Key: 254299467
• Report Number: 2134265-2021-07215
• Device Sequence Number: 1
• Product Code: KGZ
• UDI-Device Identifier: 08714729194514
• UDI-Public: 08714729194514
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 05/12/2021
• Initial Date FDA Received: 06/04/2021
• Supplement Dates Manufacturer Received: 06/09/2021
• Supplement Dates FDA Received: 07/02/2021
• Patient Sequence Number: 1