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 12/27/2021

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by manufacturer: an introducer sheath, and sheath dilator and unknown guidewire was returned for analysis.Visual inspection revealed that the introducer sheath and sheath dilator were observed that the distal tip was torn.The unknown guidewire was observed damage at distal tip.No other issues or damage were observed.

Event Description

Reportable based on device investigation completed on 17feb2022.It was reported that the introducer wire got unraveled.The target lesion was located in the kidney.A.038 accustick ii system was selected for use.During the procedure, it was noted that the introducer wire was caught on the introducer and got unraveled in the process of getting out of the introducer.The procedure was completed with another of the same device.There were no complications reported.However, device investigations revealed that the introducer sheath and sheath dilator were observed torn.

• Brand Name: ACCUSTICK II
• Type of Device: 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: 13726922
• MDR Text Key: 287122974
• Report Number: 2134265-2022-02548
• Device Sequence Number: 1
• Product Code: KGZ
• UDI-Device Identifier: 08714729157601
• UDI-Public: 08714729157601
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/10/2022

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
• Device Operator: Health Professional
• Device Model Number: 35615
• Device Catalogue Number: 35615
• Device Lot Number: 0028150786
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/17/2022
• Initial Date FDA Received: 03/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/06/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1