MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. .IMPRESS®.BRAIDED CATHETER; PERIPHERAL CATHETERS

Catalog Number	512538BER
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/27/2021
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 cerebral venography with possible angioplasty procedure, the 5f catheter tip detached within the patient's venous system.Due to the location and size of the foreign body, the tip could not be successfully removed.The foreign body was too difficult to reach, the decision was made to leave the foreign body within the patient.The patient is under observation and is in stable condition with no additional related complications to report.
Additional Manufacturer Narrative
Part of the suspect device has been returned for evaluation.The device was examined visually and microscopically.The complaint is confirmed.The root cause could not be determined however, it is likely that significant force was applied to the device during clinical use.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 CATHETER
• Common Device Name: PERIPHERAL CATHETERS
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan UT 84095
• Manufacturer (Section G): MERIT MEDICAL MANUFACTURING; 14646 kirby dr; houston TX 77047
• Manufacturer Contact: bryson heaton ; 1600 merit parkway; south jordan, UT 84095 ; 8012084662
• MDR Report Key: 12781043
• Report Number: 3010665433-2021-00104
• Device Sequence Number: 17037170
• Product Code: DQO
• UDI-Device Identifier: 00884450009253
• UDI-Public: 884450009253
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2021

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: 10/31/2022
• Device Catalogue Number: 512538BER
• Device Lot Number: E1711943
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2021
• Supplement Date Received by Manufacturer: 01/25/2022
• Initial Report FDA Received Date: 11/09/2021
• Supplement Report FDA Received Date: 02/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/02/2019
• 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: Life Threatening; Required Intervention
• Patient Sex: Unknown