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	12/26/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the radio opaque marker was detached.An accustick kit ii was selected for use.During the device preparation, outside the patient 's body, it was noted that the radio opaque marker was detached.The procedure was completed with another of the same device.There were no complications reported and the patient is stable.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis and was inspected.The ro marker was observed in the device middle section and it was loose.Moreover, under microscope damage at the distal tip of the device was observed.This damage is located next to correct ro marker position.It is important to mention that evidence of correct ro marker colocation was observed at the device distal end section and it was measured in order to confirm the correct ro marker measurement.The results were within specification; consequently, the reported complaint was confirmed.
Event or Problem Description
It was reported that the radio opaque marker was detached.An accustick kit ii was selected for use.During the device preparation, outside the patient 's body, it was noted that the radio opaque marker was detached.The procedure was completed with another of the same device.There were no complications reported and the patient is stable.

• Brand Name: ACCUSTICK II
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13296630
• Report Number: 2134265-2022-00303
• Device Sequence Number: 4796060
• Product Code: KGZ
• UDI-Device Identifier: 08714729201137
• UDI-Public: 08714729201137
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2022

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: 11/07/2024
• Device Model Number: 35615
• Device Catalogue Number: 35615
• Device Lot Number: 0028347650
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/27/2021
• Supplement Date Received by Manufacturer: 01/31/2022
• Initial Report FDA Received Date: 01/19/2022
• Supplement Report FDA Received Date: 02/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/08/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown