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

Model Number	35615
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient identifier: (b)(6).Age at time of event: 18 years or older.
Event or Problem Description
It was reported that the marker was not visible.An accustick ii was selected for use.During the procedure, it was noted that the distal radiopaque marker was not visible on imaging.The device was removed and checked under imaging externally, it was identified that the marker was located in the middle of the needle shaft rather at the distal tip.The procedure was completed with another of the same device.No patient complications reported.
Additional Manufacturer Narrative
A1.Patient identifier: mrn: (b)(6).A2.Age at time of event: 18 years or older.Device evaluated by manufacturer: the device was returned for analysis.Visual inspection revealed the ro marker was in the device middle section.The device was inspected under microscope and rag marks were observed along the device.These marks are located in the space between the correct ro marker position and the current position.It is important to mention that evidence of correct ro marker colocation was observed at device distal end section.The device was measured in order to confirm the correct ro marker position and it was in wrong position.
Event or Problem Description
It was reported that the marker was not visible.An accustick ii was selected for use.During the procedure, it was noted that the distal radiopaque marker was not visible on imaging.The device was removed and checked under imaging externally, it was identified that the marker was located in the middle of the needle shaft rather at the distal tip.The procedure was completed with another of the same device.No patient complications reported.It was further reported that there was no visual issue/damage noted on the device prior to use.The procedure was completed using a replacement device and the patient was fine post procedure.

• 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: 12543921
• Report Number: 2134265-2021-12124
• Device Sequence Number: 14473161
• Product Code: KGZ
• UDI-Device Identifier: 08714729157588
• UDI-Public: 08714729157588
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2021

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: 03/18/2024
• Device Model Number: 35615
• Device Catalogue Number: 35615
• Device Lot Number: 0026999039
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2021
• Initial Date Received by Manufacturer: 09/06/2021
• Supplement Date Received by Manufacturer: 10/04/2021
• Initial Report FDA Received Date: 09/28/2021
• Supplement Report FDA Received Date: 10/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1