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

Model Number	35615
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, that device contamination occurred.A.038j accustick ii system was selected for use.Prior to procedure, it was noted, that a hair is evident inside the packaging.The procedure was completed successfully.There were no patient complications.
Additional Manufacturer Narrative
E1 - initial reporter facility name: (b)(6).E1.Initial reporter address (b)(6).
Additional Manufacturer Narrative
The complaint device was not returned by the customer; nevertheless, physician has provided pictures of the device.As per pictures provided, it can be observed a hair through the unopened pouch.Also, it was observed that the pouch information matches with the complaint information.No more damages were observed.E1 - initial reporter facility name: (b)(6).E1.Initial reporter address (b)(6).
Event or Problem Description
It was reported that device contamination occurred.A.038j accustick ii system was selected for use.Prior to procedure, it was noted that a hair is evident inside the packaging.The procedure was completed successfully.There were no patient complications.

• Brand Name: ACCUSTICK II
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17073089
• Report Number: 2124215-2023-26579
• Device Sequence Number: 12233843
• Product Code: KGZ
• UDI-Device Identifier: 08714729157588
• UDI-Public: 08714729157588
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2023

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: 01/17/2026
• Device Model Number: 35615
• Device Catalogue Number: 35615
• Device Lot Number: 0030874098
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/15/2023
• Supplement Date Received by Manufacturer: 08/08/2023
• Initial Report FDA Received Date: 06/06/2023
• Supplement Report FDA Received Date: 08/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2023
• 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