MAUDE Adverse Event Report: IMPRESS®; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	00884450043509
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/23/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device has been returned for evaluation.A follow up will be submitted when the evaluation is complete.
Event or Problem Description
Account alleges that an impress catheter tip broke off inside a patient.Catheter was inserted over the wire and advanced into the kidney.Wire was removed and they noticed the black tip of the catheter was no longer on the end of catheter.Catheter tip was removed via snare and used another catheter and proceeded without incident.No patient harm.
Additional Manufacturer Narrative
The suspect device has been returned for evaluation.The complaint is confirmed.The root cause is attributed to the manufacturing process.A search of the complaint database was performed and no similar complaints for this lot number were found.The device history record was reviewed, and no exception documents were found.

• Brand Name: IMPRESS®
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• MDR Report Key: 11809228
• Report Number: 3010665433-2021-00030
• Device Sequence Number: 3098767
• Product Code: DQO
• UDI-Device Identifier: 00884450043509
• UDI-Public: 00884450043509
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K093004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2021

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: 12/08/2023
• Device Model Number: 00884450043509
• Device Catalogue Number: 54038KA2-H
• Device Lot Number: E2001990
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2021
• Initial Date Received by Manufacturer: 04/24/2021
• Supplement Date Received by Manufacturer: 07/20/2021
• Initial Report FDA Received Date: 05/11/2021
• Supplement Report FDA Received Date: 07/20/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/13/2021
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention