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

Catalog Number	512538BER
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/23/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The account alleges that during a left common carotid artery [lcca], thrombectomy procedure, the catheter tip detached within the patient.The physician had acquired successful vascular access and had placed a long sheath for extra vascular support and deliverability to the patients lcca via co-axial technique.After successful catheter placement within the lcca the 5f catheter tip detached.The physician used a neurovascular catheter to successfully externalized part of the foreign body however, the foreign body fragmented, and a piece of the catheter remains within the patient.
Additional Manufacturer Narrative
The suspect device is expected to return for evaluation.A follow-up report will be submitted once the evaluation is complete.
Additional Manufacturer Narrative
The suspect medical device was returned for evaluation.The device was examined visually and microscopically.The complaint is confirmed.The root cause could not be determined however, product may have been exposed to conditions outside of those identified on product and ifu including exposure to chemicals used during decontamination / sterilization of clinical environments or extreme environmental conditions during storage.The device history record was reviewed, and no exception documents were found.A search of the complaint database was performed and no similar complaints for this lot number were identified.

• Brand Name: IMPRESS®.BRAIDED.
• 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: 15941601
• Report Number: 3010665433-2022-00138
• Device Sequence Number: 20386089
• Product Code: DQO
• UDI-Device Identifier: 00884450035887
• UDI-Public: 884450035887
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• 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): 11/23/2022

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: 12/15/2023
• Device Catalogue Number: 512538BER
• Device Lot Number: E2012726
• 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: 11/23/2022
• Supplement Date Received by Manufacturer: 01/31/2023
• Initial Report FDA Received Date: 12/08/2022
• Supplement Report FDA Received Date: 02/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/21/2021
• 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; LONG DESTINATION SHEATH - PINNICAL; SOFIA MICROVENTION-CATHETER
• Outcome Attributed to Adverse Event: Other; Required Intervention; Hospitalization
• Patient Sex: Unknown