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

Model Number	38275
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	02/17/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a tip detachment occurred.An imager ii angiographic catheter was selected for use in a left leg diagnostic angiogram procedure.During preparation upon removal from packaging, the catheter was noted to be fractured 1mm proximal to the tip.The device fragment was dangling.The device never entered the body.Another device was used to complete the procedure.No patient complications were reported, and the patient was stable post procedure.
Event or Problem Description
It was reported that a tip detachment occurred.An imager ii angiographic catheter was selected for use in a left leg diagnostic angiogram procedure.During preparation upon removal from packaging, the catheter was noted to be fractured 1mm proximal to the tip.The device fragment was dangling.The device never entered the body.Another device was used to complete the procedure.No patient complications were reported, and the patient was stable post procedure.It was further reported that the device was flushed with saline.
Event or Problem Description
It was reported that a tip detachment occurred.An imager ii angiographic catheter was selected for use in a left leg diagnostic angiogram procedure.During preparation upon removal from packaging, the catheter was noted to be fractured 1mm proximal to the tip.The device fragment was dangling.The device never entered the body.Another device was used to complete the procedure.No patient complications were reported, and the patient was stable post procedure.It was further reported that the device was flushed with saline.
Additional Manufacturer Narrative
Device evaluated by manufacturer: returned product consisted of an imager ii catheter.Visual and microscope examination of the tip revealed it was separated 25mm from the distal end.Materials analysis lab (mtac) found that there was polymer degradation which likely contributed to the confirmed detachment.Inspection of the remainder of the device, apart from the observed damage revealed no other damage or irregularities.

• Brand Name: IMAGER II ANGIOGRAPHIC CATHETER
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• MDR Report Key: 11455724
• Report Number: 2134265-2021-03078
• Device Sequence Number: 19609424
• Product Code: DQO
• UDI-Device Identifier: 08714729405016
• UDI-Public: 08714729405016
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K120893
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/29/2021

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: 02/05/2022
• Device Model Number: 38275
• Device Catalogue Number: 38275
• Device Lot Number: 0000149174
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2021
• Initial Date Received by Manufacturer: 02/17/2021
• Supplement Date Received by Manufacturer: 03/11/2021; 04/08/2021
• Initial Report FDA Received Date: 03/10/2021
• Supplement Report FDA Received Date: 04/05/2021; 04/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/05/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1