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

Catalog Number	510038CB1
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Codes	Ischemia (1942); Obstruction/Occlusion (2422); Foreign Body In Patient (2687); Foreign Body Embolism (4439)
Date of Event	05/05/2022
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 diagnostic endovascular procedure, the catheter had detached twice within the patient.The physician had acquired vascular access and during catheter manipulations over a guidewire, under fluoroscopy, the catheter detached.The physician was able to successfully externalize only one foreign body from the patient with a vascular snare device.The other foreign body that detached became stuck within the patient's leg.No additional patient consequences to report.
Additional Manufacturer Narrative
The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.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: PERIPHERAL CATHETERS
• 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; 8012084662
• MDR Report Key: 14570743
• Report Number: 3010665433-2022-00055
• Device Sequence Number: 20094147
• Product Code: DQO
• UDI-Device Identifier: 00884450038161
• UDI-Public: 884450038161
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• 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): 05/07/2022

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 Catalogue Number: 510038CB1
• Device Lot Number: E1944693
• 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: Not provided
• Supplement Date Received by Manufacturer: 07/27/2022
• Initial Report FDA Received Date: 06/01/2022
• Supplement Report FDA Received Date: 08/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2020
• 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: GUIDWIRE.
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown