MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. MERIT S-MAK; DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Model Number	00884450012635
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
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.We explored the superficial area along the skin and subcutaneous tissue at the entry site to see if we could identify the distal part and remove it.We were unable to visualize it.We did not see it on fluoroscopy either.I then elected to place a 16 french long sheath over our guidewire.Using the same sheath, i advanced in and snare and grasped the distal end of the j-wire to avoid distal embolization of this.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 we were able to identify the broken fragment of the micropuncture sheath.This was carefully assessed to ensure that the entire fragment was removed without any retained fragments.

• Brand Name: MERIT S-MAK
• Common Device Name: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 1600 west merit parkway; south jordan UT 84095
• MDR Report Key: 17360525
• Report Number: 17360525
• Device Sequence Number: 5152215
• Product Code: DRE
• UDI-Device Identifier: 00884450012635
• UDI-Public: (01)00884450012635
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 07/07/2023
• Report Date (Section F): 07/07/2023

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 Model Number: 00884450012635
• Device Catalogue Number: S-MAK401N/C
• Device Lot Number: I2633575
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 07/20/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/20/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 79 KG
• Patient Race: White
• Date Report Sent to FDA: 07/07/2023