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

Catalog Number	53035BER
Medical Device Problem Codes	Fracture (1260); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/17/2020
Type of Reportable Event	Malfunction
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 peripheral vascular aneurysm repair procedure, the catheter tip was damaged, and a piece of the catheter detached within the patient.The physician had acquired retrograde right femoral artery access and had negotiated the patient's common iliac bifurcation with a guidewire and the 5f catheter.During the placement of intravascular coils within the targeted common iliac aneurysm, a coil perforated the distal tip of the catheter causing part of the catheter tip to detach and migrate distally within the patient's left leg.The physician was unable to identify the foreign body under fluoro/cine imaging.The physician did not attempt to retrieve the detached tip from the patient.
Additional Manufacturer Narrative
The suspect device has been returned for evaluation.The device was examined visually, the device arrived with the tip attached to the catheter body and some remnants of a damaged guidewire were identified.The complaint could not be confirmed.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.

• Brand Name: IMPRESS®
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• MDR Report Key: 10610024
• Report Number: 3010665433-2020-00038
• Device Sequence Number: 13751201
• Product Code: DQO
• UDI-Device Identifier: 00884450015551
• UDI-Public: 884450015551
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2020
• Device Catalogue Number: 53035BER
• Device Lot Number: E1243502
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2020
• Initial Date Received by Manufacturer: 09/17/2020
• Supplement Date Received by Manufacturer: 11/12/2020
• Initial Report FDA Received Date: 09/30/2020
• Supplement Report FDA Received Date: 11/18/2020
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/07/2017
• 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