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

Model Number 38270

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/12/2020

Event Type  Injury  

Event 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 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.

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
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• MDR Report Key: 11003786
• MDR Text Key: 221542108
• Report Number: 2134265-2020-17440
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 08714729355144
• UDI-Public: 08714729355144
• Combination Product (y/n): N
• PMA/PMN Number: K121694
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 12/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 12/02/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/18/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 92484513-FA
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Weight: 53