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

Catalog Number 512538BER

Device Problems Fracture (1260); Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/23/2022

Event Type  Injury  

Event 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.

Manufacturer Narrative

The suspect device is expected to return for evaluation.A follow-up report will be submitted once the evaluation is complete.

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.
• Type of Device: 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
• MDR Text Key: 305079162
• Report Number: 3010665433-2022-00138
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00884450035887
• UDI-Public: 884450035887
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: K053171
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 11/23/2022
• Initial Date FDA Received: 12/08/2022
• Supplement Dates Manufacturer Received: 01/31/2023
• Supplement Dates FDA Received: 02/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/21/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: INTERVENTIONAL GUIDWIRE; LONG DESTINATION SHEATH - PINNICAL; SOFIA MICROVENTION-CATHETER
• Patient Outcome(s): Other; Required Intervention; Hospitalization