MAUDE Adverse Event Report: IMPRESS®.BRAIDED CATHETER; DIAGNOSTIC PERIPHERAL CATHETER.

Catalog Number	46535RIM
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/18/2021
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 percutaneous transluminal angioplasty [pta] procedure, the catheter tip detached within the patient.The physician had acquired right retrograde femoral artery access and had negotiated the patient's common iliac bifurcation with a guidewire and the 4f catheter.During catheter manipulations over the wire within the patient's artery, the catheter tip detached.The physician used a vascular stent to pin the foreign body in place to prevent possible migration.The patient tolerated the procedure well with no additional consequences to report.
Additional Manufacturer Narrative
Part of the suspect device has been returned for evaluation.The device was examined visually.The complaint is confirmed.The root cause could not be determined however, it is likely that significant force was applied to the device during clinical use.Damages observed on this tip section had the look of being elongated and stretched.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®.BRAIDED CATHETER
• Common Device Name: DIAGNOSTIC PERIPHERAL CATHETER.
• MDR Report Key: 11667617
• Report Number: 3010665433-2021-00019
• Device Sequence Number: 3098253
• Product Code: DQO
• UDI-Device Identifier: 00884450038109
• UDI-Public: 884450038109
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 03/18/2021

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: 10/31/2022
• Device Catalogue Number: 46535RIM
• Device Lot Number: E1707693
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2021
• Initial Date Received by Manufacturer: 03/18/2021
• Supplement Date Received by Manufacturer: 06/08/2021
• Initial Report FDA Received Date: 04/14/2021
• Supplement Report FDA Received Date: 06/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/14/2019
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GUIDEWIRE
• Outcome Attributed to Adverse Event: Required Intervention