MAUDE Adverse Event Report: MERIT MEDICAL MANUFACTURING IMPRESS®.BRAIDED CAHTETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number	59038UAC
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/14/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device is expected to return for investigation.A follow-up report will be submitted once the investigation is complete.
Event or Problem Description
The account alleges that during a peripheral vascular intervention, a catheter tip detached within the patient.The physician had acquired retrograde femoral artery access and had negotiated the patient's ilio-femoral bifurcation with a guidewire and the 5f catheter.During catheter manipulations, the catheter tip detached in the patient's common iliac artery.The physician used a vascular snare device to capture and externalized the foreign body.During the primary capture attempt of the foreign body, it fragmented again into two additional pieces.A secondary attempt to capture and remove the foreign body was attempted, and the foreign body again fractured into two additional pieces within the patient's peripheral vasculature system.A third attempt was made resulting in the same outcome for the patient.The patient was admitted and transferred to the surgical unit for foreign body removal.
Additional Manufacturer Narrative
The suspect device was not returned for evaluation.The complaint could not be confirmed.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®.BRAIDED CAHTETER
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): MERIT MEDICAL MANUFACTURING; 14646 kirby dr; houston TX 77047
• Manufacturer (Section G): MERIT MEDICAL MANUFACTURING; 14646 kirby dr; houston TX 77047
• Manufacturer Contact: bryson heaton bsn,rn. ; 1600 merit parkway; south jordan, UT 84095
• MDR Report Key: 15894708
• Report Number: 3010665433-2022-00130
• Device Sequence Number: 17840912
• Product Code: DQO
• UDI-Device Identifier: 00884450109373
• UDI-Public: 884450109373
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K053171
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2022

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: 05/19/2023
• Device Catalogue Number: 59038UAC
• Device Lot Number: E1841820
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2022
• Supplement Date Received by Manufacturer: 03/02/2023
• Initial Report FDA Received Date: 12/01/2022
• Supplement Report FDA Received Date: 03/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/26/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: INTERVENTIONAL GUIDWIRE
• Outcome Attributed to Adverse Event: Required Intervention; Other; Hospitalization
• Patient Sex: Unknown