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

Model Number	38270
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/12/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that tip detachment occurred.A 5fr imager ii angiographic catheter was selected for a splenic artery embolization procedure.A femoral approach was used to access the mildly calcified eccentrically shaped lesion.The anatomy was not tortuous.During the procedure, the tip of the catheter detached inside the patient.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.
Event or Problem Description
It was reported that tip detachment occurred.A 5fr imager ii angiographic catheter was selected for a splenic artery embolization procedure.A femoral approach was used to access the mildly calcified eccentrically shaped lesion.The anatomy was not tortuous.During the procedure, the tip of the catheter detached inside the patient.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.It was further reported that the imager was being introduced through a 6f sheath at the time of the tip detachment.Approximately 3-5cm of the tip detached.The tip was retrieved with a snare.There were no patient complications.
Additional Manufacturer Narrative
Updated: adverse event/product problem, outcomes attributed to adv event, describe event or problem, type of reportable event.

• Brand Name: IMAGER II ANGIOGRAPHIC CATHETER
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• MDR Report Key: 11003786
• Report Number: 2134265-2020-17440
• Device Sequence Number: 3477615
• Product Code: DQO
• UDI-Device Identifier: 08714729355144
• UDI-Public: 08714729355144
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K121694
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2020

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: 09/18/2021
• Device Model Number: 38270
• Device Catalogue Number: 38270
• Device Lot Number: 0000145249
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/26/2020
• Supplement Date Received by Manufacturer: 12/02/2020
• Initial Report FDA Received Date: 12/14/2020
• Supplement Report FDA Received Date: 12/17/2020
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/18/2019
• 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: Required Intervention
• Patient Age: 64 YR
• Patient Weight: 53