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	01/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was cancelled.An accustick ii w/o guidewire was selected for use.During the procedure, it was noted that the wire is jammed in the sheath and the sheath comes out.The device was replaced with the same product, however, the same issue was encountered.The procedure was not completed due to this event.There were no complications reported.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.One accustick device was returned for analysis: introducer cannula, dilator and sheath and no issues were found.The device was inspected under microscope and no issues or damages were observed.
Event or Problem Description
It was reported that the procedure was cancelled.An accustick ii w/o guidewire was selected for use.During the procedure, it was noted that the wire is jammed in the sheath and the sheath comes out.The device was replaced with the same product, however, the same issue was encountered.The procedure was not completed due to this event.There were no complications reported.It was further reported, that the sheath could not penetrate into the body and this malfunction occurred continuously with the same product, however, the procedure was completed with another product.

• 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: 13419884
• Report Number: 2134265-2022-00877
• Device Sequence Number: 4676146
• Product Code: KGZ
• UDI-Device Identifier: 08714729157625
• UDI-Public: 08714729157625
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2022

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: 11/21/2024
• Device Model Number: 35615
• Device Catalogue Number: 35615
• Device Lot Number: 0028477903
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/10/2022
• Supplement Date Received by Manufacturer: 02/12/2022
• Initial Report FDA Received Date: 02/01/2022
• Supplement Report FDA Received Date: 03/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/22/2021
• 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