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

Catalog Number	510038VER/CN
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device is expected to return for evaluation.A follow-up report will be submitted once the evaluation is complete.
Event or Problem Description
The account alleges that during peripheral vascular arteriography, the catheter tip detached within a patient.The physician had acquired retrograde femoral artery access and had negotiated the patient's ilio-femoral conduit with a guidewire and a 5f catheter.During over-the-wire catheter manipulations under fluoroscopy within the patient's common iliac artery.The foreign body remained within the patient.No additional patient consequences to report.
Additional Manufacturer Narrative
The suspect medical device was not returned for evaluation.The complaint is confirmed.The root cause could not be determined.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.Should the device be returned later, the investigation will be reopened.

• Brand Name: IMPRESS®.BRAIDED CATHETER
• Common Device Name: 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: 17309363
• Report Number: 3010665433-2023-00057
• Device Sequence Number: 20459659
• Product Code: DQO
• UDI-Device Identifier: 00884450009222
• UDI-Public: 884450009222
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 06/28/2023

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: 07/21/2023
• Device Catalogue Number: 510038VER/CN
• Device Lot Number: E1840116
• 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: 06/28/2023
• Supplement Date Received by Manufacturer: 10/31/2023
• Initial Report FDA Received Date: 07/12/2023
• Supplement Report FDA Received Date: 11/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (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
• Concomitant Medical Products and Therapy/Usage Dates: INTERVENTIONAL GUIDEWIRE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown