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

Model Number	00884450009222
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/11/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
Event or Problem Description
The account alleges that during the procedure, the tip of the device was fractured and left in the patient's body, which was removed from the body by a capture device.
Additional Manufacturer Narrative
The suspect device was not returned for evaluation.A video tape was provided by the account confirming the complaint.The root cause could not be determined.The device history record was reviewed, and no exception documents were found.A search of the complaint database was performed and no similar complaints for this lot number were identified.Should the device be returned at a later date, the investigation will be re-opened.

• Brand Name: IMPRESS®
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• MDR Report Key: 12009887
• Report Number: 3010665433-2021-00042
• Device Sequence Number: 19894440
• Product Code: DQO
• UDI-Device Identifier: 00884450009222
• UDI-Public: 00884450009222
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K053171
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2021

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: 09/30/2022
• Device Model Number: 00884450009222
• Device Catalogue Number: 510038VER/CN
• Device Lot Number: E1693123
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/20/2021
• Supplement Date Received by Manufacturer: 08/16/2021
• Initial Report FDA Received Date: 06/16/2021
• Supplement Report FDA Received Date: 08/18/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/30/2019
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention