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

Model Number	00884450020043
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/05/2020
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 peripheral vascular procedure, the catheter tip detached within the patient.The physician had acquired retrograde arterial 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 aortic bifurcation the catheter tip detached.A contralateral femoral retrograde arterial access was necessary to successfully retrieve the broken tip with a vascular snare device.The secondary access site resulted in a false aneurysm which made a secondary procedural intervention necessary within the surgical arena under general anesthesia.
Additional Manufacturer Narrative
The suspect device has been returned for evaluation.The product was examined visually.The complaint is confirmed.No definitive root cause could be determined however, it is likely that significant force was applied to the device during use.A search of the complaint database found no similar complaint for this lot number from the same customer.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
• MDR Report Key: 9920866
• Report Number: 3010665433-2020-00007
• Device Sequence Number: 3271967
• Product Code: DQO
• UDI-Device Identifier: 00884450020043
• UDI-Public: 00884450020043
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K053171
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2020

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: 09/30/2022
• Device Model Number: 00884450020043
• Device Catalogue Number: 410038BER
• Device Lot Number: E1674641
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2020
• Initial Date Received by Manufacturer: 03/06/2020
• Supplement Date Received by Manufacturer: 05/19/2020
• Initial Report FDA Received Date: 04/03/2020
• Supplement Report FDA Received Date: 06/18/2020
• 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