MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. IMPRESS PERIPHERAL CATHETER

Catalog Number	46535RIM
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/11/2019
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 retrograde femoral artery access and had negotiated the patient's common iliac bifurcation with a guidewire and the 4f catheter.During catheter removal the catheter tip detached within the patient's artery.The physician used two vascular snare devices' to successfully retrieve the catheter tip from the patient's periphery with no additional adverse consequences.
Additional Manufacturer Narrative
The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.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.Corrective actions are in process.

• Brand Name: IMPRESS PERIPHERAL CATHETER
• Common Device Name: PERIPHERAL CATHETER
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 14646 kirby drive; houston TX 77047
• MDR Report Key: 9501076
• Report Number: 3010665433-2019-00087
• Device Sequence Number: 1189460
• Product Code: DQO
• UDI-Device Identifier: 00884450009222
• UDI-Public: 884450009222
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K053171
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2019

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: 01/31/2022
• Device Catalogue Number: 46535RIM
• Device Lot Number: E1514817
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/11/2019
• Supplement Date Received by Manufacturer: 04/07/2020
• Initial Report FDA Received Date: 12/20/2019
• Supplement Report FDA Received Date: 04/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Weight: 70