MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION IMAGER II ANGIOGRAPHIC CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number 38270

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/08/2023

Event Type  malfunction  

Manufacturer Narrative

Initial reporter address 1: (b)(6).Mfr site state: (b)(4).

Event Description

It was reported that tip detachment occurred.An imager ii was selected for use in a venography venoplasty procedure.During the procedure, the grey part of the device was broken.No patient complications were reported.

• Brand Name: IMAGER II ANGIOGRAPHIC CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): TELEFLEX MEDICAL; unit 7 8 and 9; annacotty ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16485359
• MDR Text Key: 310693647
• Report Number: 2124215-2023-09926
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 08714729354888
• UDI-Public: 08714729354888
• Combination Product (y/n): N
• Reporter Country Code: ID
• PMA/PMN Number: K121694
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 03/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/19/2024
• Device Model Number: 38270
• Device Catalogue Number: 38270
• Device Lot Number: 0000164729
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 92484513-FA
• Patient Sequence Number: 1