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

Model Number	00884450042489
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/31/2020
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 an angiography post-bricker's procedure, neobladder procedure, the tip of the catheter detached within the neonatal patient.The physician had acquired vascular access and during catheter manipulations over the wire, the catheter tip detached.Several unsuccessful attempts to retrieve the foreign body from the patient had been tried.The decision was made to leave the foreign body within the patient until it could be surgically removed during a follow up surgery scheduled for the patient on a later date.
Additional Manufacturer Narrative
The suspect device has been returned for evaluation.The complaint is confirmed.The root cause is attributed to the manufacturing process.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.BRAIDED PERIPHERIAL CATHETER
• Common Device Name: PERIPHERIAL CATHETER
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 14646 kirby drive; houston, tx
• MDR Report Key: 9989049
• Report Number: 3010665433-2020-00013
• Device Sequence Number: 3675819
• Product Code: DQO
• UDI-Device Identifier: 00884450042489
• UDI-Public: 00884450042489
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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): 03/31/2020

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: 12/30/2022
• Device Model Number: 00884450042489
• Device Catalogue Number: 44038KA2
• Device Lot Number: E1754103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2020
• Initial Date Received by Manufacturer: 03/31/2020
• Supplement Date Received by Manufacturer: 06/15/2020
• Initial Report FDA Received Date: 04/22/2020
• Supplement Report FDA Received Date: 07/01/2020
• 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: Hospitalization; Other; Required Intervention