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

Model Number	38265
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)
Date of Event	07/13/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the tip detached inside the patient.A 5f pigtail imager ii angiographic catheter was selected for an inferior vena cava (ivc) filter procedure.During the procedure, the catheter tip fractured inside the patient.Under fluoroscopy, five fragments were seen in the back of the patient's lungs.Attempts were made to retrieve the fragments with the use of a snare; however, not all fragments were able to be retrieved.The patient was asymptomatic during the procedure and was stable post-procedure.The patient was discharged home in stable condition.
Additional Manufacturer Narrative
Device evaluated by manufacturer: returned product consisted of an imager diagnostic catheter.Visual examination of the device revealed that a multiple bends and kinks.Microscope examination revealed that the tip had detached approximately 3.0cm from the tip.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 the tip detached inside the patient.A 5f pigtail imager ii angiographic catheter was selected for an inferior vena cava (ivc) filter procedure.During the procedure, the catheter tip fractured inside the patient.Under fluoroscopy, five fragments were seen in the back of the patient's lungs.Attempts were made to retrieve the fragments with the use of a snare; however, not all fragments were able to be retrieved.The patient was asymptomatic during the procedure and was stable post-procedure.The patient was discharged home in stable condition.

• Brand Name: IMAGER II ANGIOGRAPHIC CATHETER
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• MDR Report Key: 10476508
• Report Number: 2134265-2020-11704
• Device Sequence Number: 2880311
• Product Code: DQO
• UDI-Device Identifier: 08714729355878
• UDI-Public: 08714729355878
• Combination Product (Y/N): N
• Initial Reporter Country: JM
• 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,distri
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/12/2021
• Device Model Number: 38265
• Device Catalogue Number: 38265
• Device Lot Number: 0000138771
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2021
• Initial Date Received by Manufacturer: 08/04/2020
• Supplement Date Received by Manufacturer: 04/06/2021
• Initial Report FDA Received Date: 09/01/2020
• Supplement Report FDA Received Date: 04/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/12/2019
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 92484513-FA
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 49 YR