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

Model Number	00884450026571
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/20/2020
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 interventional procedure, the catheter tip detached within the patients artery.The physician had acquired retrograde femoral artery access and had negotiated the patient's common iliac bifurcation with a stiff guide wire and 4f catheter.During a catheter exchange, the catheter tip detached within the patients common femoral artery and remained on the guide wire.It was noted that the patient had previous femoral artery surgery, scar tissue was note.The physician up sized the sheath to 6f, so that the guide wire and detached catheter tip could be removed together through the larger sheath.The catheter tip was just protruding from access site during removal, so the physician was able to finally remove the tip by hand.A new catheter was then introduced, and the procedure was successfully completed.A vascular stent was successfully placed within the patients superficial femoral and popliteal arteries with no additional complications to report.
Additional Manufacturer Narrative
The suspect device has been returned for evaluation.The product was examined visually and microscopically.The complaint is confirmed.No definitive root cause could be determined however, the most probable cause is forces imposed upon the device when resistance occurred during the clinical procedure.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 NON-BRAIDED PERIPHERAL CATHETER
• Common Device Name: PERIPHERAL CATHETER
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 14646 kirby drive; houston, tx
• MDR Report Key: 10171725
• Report Number: 3010665433-2020-00017
• Device Sequence Number: 2142870
• Product Code: DQO
• UDI-Device Identifier: 00884450026571
• UDI-Public: 00884450026571
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 05/20/2020

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: 07/31/2022
• Device Model Number: 00884450026571
• Device Catalogue Number: 4903510PIG-NB
• Device Lot Number: E1639145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2020
• Initial Date Received by Manufacturer: 05/20/2020
• Supplement Date Received by Manufacturer: 08/05/2020
• Initial Report FDA Received Date: 06/18/2020
• Supplement Report FDA Received Date: 08/18/2020
• 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