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

Model Number	38260
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	02/22/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a tip detachment occurred.Two 4f imager ii angiographic catheters were selected for use in a lower leg angiogram procedure.During preparation outside the body, the tips of the devices came off.Another device was used to complete the procedure.No patient complications were reported, and the patient was stable post procedure.
Additional Manufacturer Narrative
D4: lot number: the lot number changed from 0000149174 to 0000149039.Device evaluated by manufacturer: returned product consisted of imager pigtail catheters.Visual and microscopic examination of the device revealed that the device had a kink 26 cm from the hub.There was a partial separation 67.2 from the hub and a complete separation 67.8cm from hub.There were witness marks on the tip which indicates that the device was pulled through the tabs on the product card and not lifted up from the product card.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.
Event or Problem Description
It was reported that a tip detachment occurred.Two 4f imager ii angiographic catheters were selected for use in a lower leg angiogram procedure.During preparation outside the body, the tips of the devices came off.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.Two 4f imager ii angiographic catheters were selected for use in a lower leg angiogram procedure.During preparation outside the body, the tips of the devices came off.Another device was used to complete the procedure.No patient complications were reported, and the patient was stable post procedure.
Additional Manufacturer Narrative
D4 - lot number: updated.

• Brand Name: IMAGER II ANGIOGRAPHIC CATHETER
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• MDR Report Key: 11499115
• Report Number: 2134265-2021-03296
• Device Sequence Number: 14755299
• 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): 04/28/2021

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: 01/28/2022
• Device Model Number: 38260
• Device Catalogue Number: 38260
• Device Lot Number: 0000149039
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2021
• Initial Date Received by Manufacturer: 02/22/2021
• Supplement Date Received by Manufacturer: 03/16/2021; 04/08/2021
• Initial Report FDA Received Date: 03/16/2021
• Supplement Report FDA Received Date: 04/08/2021; 04/28/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/28/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1