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

Model Number	00884450018897
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/03/2021
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 a procedure the distal end of the stiff guidewire catheter ruptured while in the left superficial femoral crossover.Removal of the lead was difficult and the rupture occurred when crossing the aortofemoral bifurcation.The device was removed using a lasso.
Additional Manufacturer Narrative
The suspect device was returned for evaluation.The device was examined visually and microscopically.Functional testing was performed.The complaint was confirmed.The root cause could not be determined however, it is likely that significant force was applied to the device during clinical use.A search of the complaint database was performed and no similar complaints for this lot number were identified.The device history record was reviewed, and no exception documents were identified.

• Brand Name: IMPRESS®
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• MDR Report Key: 11809244
• Report Number: 3010665433-2021-00031
• Device Sequence Number: 3098768
• Product Code: DQO
• UDI-Device Identifier: 00884450018897
• UDI-Public: 00884450018897
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2021

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: 00884450018897
• Device Catalogue Number: 410035SIM1
• Device Lot Number: E1998213
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2021
• Initial Date Received by Manufacturer: 05/03/2021
• Supplement Date Received by Manufacturer: 06/21/2021
• Initial Report FDA Received Date: 05/11/2021
• Supplement Report FDA Received Date: 06/30/2021
• 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