MAUDE Adverse Event Report: MERIT MEDICAL MANUFACTURING IMPRESS BRAIDED CATHETER

Catalog Number	56538VER
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/19/2024
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 customer alleges that the catheter tip had broken off in a patient during a embolization.No harm has occurred to the patient and the embolization was completed.
Additional Manufacturer Narrative
The suspect device was returned for evaluation.The complaint was confirmed; however, the root cause could not be determined.Due to the jagged / brittle nature of the remaining tip material, a possible cause is that the device was exposed to external chemicals used during decontamination / sterilization of clinical environments or extreme environmental conditions during storage outside of merit's possession.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 CATHETER
• Common Device Name: BRAIDED CATHETER
• Manufacturer (Section D): MERIT MEDICAL MANUFACTURING; 14646 kirby dr; houston TX 77047
• Manufacturer (Section G): MERIT MEDICAL MANUFACTURING; 14646 kirby dr; houston, tx 77047 ; EI 77047
• Manufacturer Contact: bryson heaton bsn, rn. ; 1600 merit parkway; south jordan, UT 84095
• MDR Report Key: 20085148
• Report Number: 3010665433-2024-00029
• Device Sequence Number: 15415893
• Product Code: DQO
• UDI-Device Identifier: 00884450661581
• UDI-Public: 00884450661581
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 08/19/2024

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: 11/02/2024
• Device Catalogue Number: 56538VER
• Device Lot Number: E2280640
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2024
• Supplement Date Received by Manufacturer: 10/15/2024
• Initial Report FDA Received Date: 08/28/2024
• Supplement Report FDA Received Date: 10/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/29/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown