MAUDE Adverse Event Report: MERIT MEDICAL MANUFACTURING IMPRESS BRAIDED CATHETER

Catalog Number	54038KA2
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/14/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device was not returned for evaluation.The complaint is could not be confirmed and a root cause could not be determined.A review of the complaint database was performed and no similar complaints for this lot number were found.A review of the device history record was performed and no exception documents were identified.
Event or Problem Description
The account alleges that the patient was admitted to the hospital for pta (thrombectomy) surgery, which was expected to take 1 hour.When the merit impress angiographic catheter was used during the surgery, the tip of the catheter broke in the patient's blood vessel, causing the original 1 hour the achievable surgery was extended by 1.5 hours due to the removal of the broken tip and the addition of vascular exploration.Medical staff provided wound dressing to stop bleeding, drug treatment, blood and urine tests, etc.After the operation, and continued observation.The patient's condition was stable and no complications occurred.

• 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
• Manufacturer Contact: bryson heaton bsn, rn. ; 1600 merit parkway; south jordan, UT 84095
• MDR Report Key: 20127000
• Report Number: 3010665433-2024-00031
• Device Sequence Number: 3265971
• Product Code: DQO
• UDI-Device Identifier: 00884450654507
• UDI-Public: 00884450654507
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/27/2024

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: 01/17/2025
• Device Catalogue Number: 54038KA2
• Device Lot Number: E2322353
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2024
• Initial Report FDA Received Date: 09/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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