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

Model Number 35615

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/28/2019

Event Type  Injury  

Event Description

It was reported that a small ring was detached from the device.An accustic ii catheter was selected for use.During withdrawal, the physician noted that the small marking ring at the distal end of the system had detached and was still inside the patient.The physician carefully removed the detached component from the patient.No further patient complications reported.

• 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: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 8667406
• MDR Text Key: 146950493
• Report Number: 2134265-2019-06292
• Device Sequence Number: 1
• Product Code: KGZ
• UDI-Device Identifier: 08714729157588
• UDI-Public: 08714729157588
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K952828
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/05/2022
• Device Model Number: 35615
• Device Catalogue Number: 35615
• Device Lot Number: 0023443194
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/14/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/06/2019
• 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
• Patient Outcome(s): Required Intervention