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

Catalog Number	56538CB2/B
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2023
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 a percutaneous transluminal angioplasty [pta] procedure within the patient's periphery, a catheter tip detached.The physician had acquired right retrograde popliteal artery access and had negotiated the patient's contralateral left ilio-femoral conduit with an interventional guidewire and a 5f catheter.During catheter manipulations under fluoroscopy the catheter tip detached but remained on the guidewire.The detached catheter tip was removed along with the guidewire.No additional medical intervention was deemed necessary.A new device was used to complete this procedure.No additional patient consequences to report.
Additional Manufacturer Narrative
The suspect medical device has been returned for evaluation.The device was visually and microscopically evaluated.The complaint is confirmed.The root cause can be contributed to the manufacturing process.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.Corrective actions are in progress.

• Brand Name: .IMPRESS®.BRAIDED CATHETER
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS MEXICO; 8830 siempre viva rd #100; san diego, CA 92154
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS MEXICO; 8830 siempre viva rd #100; san diego, CA 92154
• Manufacturer Contact: bryson heaton bsn,rn. ; 1600 merit parkway; south jordan, UT 84095
• MDR Report Key: 16811832
• Report Number: 3011642792-2023-00028
• Device Sequence Number: 19592377
• Product Code: DQO
• UDI-Device Identifier: 00884450035955
• UDI-Public: 884450035955
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 04/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/20/2025
• Device Catalogue Number: 56538CB2/B
• Device Lot Number: I2516670
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2023
• Supplement Date Received by Manufacturer: 06/16/2023
• Initial Report FDA Received Date: 04/25/2023
• Supplement Report FDA Received Date: 06/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/14/2022
• 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 GUIDEWIRE.
• Patient Sex: Unknown