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	06/08/2020
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 angioplasty procedure, the catheter tip detached within the patient.The physician had successfully acquired retrograde arterial access with the 4f pig catheter.During a catheter exchange over the stiff guide wire, the tip detached within the patient's common femoral artery but remained on the wire.The physician noted the patients excessive scar tissue from previously femoral artery surgery.As the physician removed the catheter from the vascular access site, the tip of the catheter was found protruding.The physician was able to successfully remove the detached tip form the patient by hand with no additional consequences to report.
Additional Manufacturer Narrative
The suspect device was returned for evaluation.The complaint was confirmed; however, 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.

• 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: 10221201
• Report Number: 3010665433-2020-00021
• Device Sequence Number: 11331018
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2020

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: 07/31/2020
• 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: 07/07/2020
• Initial Date Received by Manufacturer: 06/08/2020
• Supplement Date Received by Manufacturer: 08/12/2020
• Initial Report FDA Received Date: 07/01/2020
• Supplement Report FDA Received Date: 08/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SUPER STIFF GUIDEWIRE - AMPLATZ