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

Model Number	38277
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 initial reporter city: (b)(6).
Event or Problem Description
It was reported that tip detachment occurred.The target lesion was located in a moderately tortuous and non-calcified vessel.A 5f imager ii diagnostic catheter was selected for use.During the procedure, the catheter tip broke when the device was moved to the diagnostic zone.The physician managed to pull it out safely from the patient.No complications were reported.

• Brand Name: IMAGER II
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): TELEFLEX MEDICAL; 1 unit 7 8 and 9; annacotty, li ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19372274
• Report Number: 2124215-2024-27676
• Device Sequence Number: 7528953
• Product Code: DQO
• UDI-Device Identifier: 08714729736165
• UDI-Public: 08714729736165
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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
• Report Date (Section B): 05/22/2024

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 Model Number: 38277
• Device Catalogue Number: 38277
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/25/2024
• Initial Report FDA Received Date: 05/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Female