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

Catalog Number	46538VER
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/04/2019
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 an angiogram the tip of the impress catheter broke off in a calcified portion of the right common iliac artery.The performing physician was then able to successfully remove the catheter tip using a snare.There was no harm to the patient.
Additional Manufacturer Narrative
The suspect device has been returned for evaluation.The product was examined visually.The complaint is confirmed.The root cause was attributed to significant force being applied to the device during use.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.

• 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: 9385076
• Report Number: 3010665433-2019-00080
• Device Sequence Number: 14005181
• Product Code: DQO
• UDI-Device Identifier: 00884450026557
• UDI-Public: 00884450026557
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• 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): 11/08/2019

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: 03/31/2022
• Device Catalogue Number: 46538VER
• Device Lot Number: E1549202
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2019
• Initial Date Received by Manufacturer: 11/08/2019
• Supplement Date Received by Manufacturer: 12/19/2019
• Initial Report FDA Received Date: 11/27/2019
• Supplement Report FDA Received Date: 01/10/2020
• 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