MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS MEXICO MERIT S-MAK¿.COAXIAL MINI ACCESS KIT.STIFFENED MINI ACCESS

Catalog Number	S-MAK401N/C
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/06/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device is not expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
Event or Problem Description
The account alleges that after obtaining vascular access, a long 032 guidewire was placed into the svc (superior vena cava).The distal part of the micropuncture sheath broke while removing it from the vasculature over the guidewire.The superficial area along the skin and subcutaneous tissue at the entry site was explored to see if the distal part could be identified and removed without success.A 16 french long sheath was placed over the guidewire.Using the same sheath, a snare was used to grasp the distal end of the j-wire.The wire and the snare were simultaneously pulled back into the long 16 french sheath.Once both were well into the sheath, another guidewire was placed to retain access.The sheath, the original 032 guidewire and the snare were all then pulled out of the vasculature.The snare and the original guidewire were then freed up from the remove sheath and the broken fragment of the micropuncture sheath was identified to ensure that the entire fragment was removed without any retained fragments.
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: MERIT S-MAK¿.COAXIAL MINI ACCESS KIT.STIFFENED MINI ACCESS
• Common Device Name: COAXIAL MINI ACCESS KIT
• 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: 17399137
• Report Number: 3011642792-2023-00051
• Device Sequence Number: 7657500
• Product Code: DRE
• UDI-Device Identifier: 00884450012635
• UDI-Public: 00884450012635
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K031691
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/20/2023

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: 03/06/2026
• Device Catalogue Number: S-MAK401N/C
• Device Lot Number: I2633575
• 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: 07/20/2023
• Supplement Date Received by Manufacturer: 08/17/2023
• Initial Report FDA Received Date: 07/26/2023
• Supplement Report FDA Received Date: 08/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2023
• 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