MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS MERIT MAK¿; DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Model Number	00884450012680
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2022
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
Patient was being treated for stroke.Post stroke, patient demonstrated cerebral vascular spasms, which required direct infusion of the vessels.A catheter was introduced through the right femoral artery and fed to the cerebral vessels.Following removal of the catheter, the vessel was sealed using the abbott starclose device.Patient had received multiple treatments during treatment and had received 4 or 5 similar catheterizations throughout the week of her treatment.Patient was again catheterized through the right femoral artery.At this point, several starclose devices were already present in the vessel.A merit medical 4fr 10cm introducer was used.During catheterization, the introducer rubbed against the starclose devices, removing a piece of the introducer tip.The broken piece was retained in the artery.Patient received additional surgery to remove the retained foreign body.The broken piece was removed without incident.
Additional Manufacturer Narrative
The suspect device is not expected to return for evaluation.The complaint could not be confirmed.The root cause could not be determined.A review of the device history and complaint database could not be performed since the lot number was not provided.Should the device be returned at a later date, the investigation will be re-opened.

• Brand Name: MERIT MAK¿
• Common Device Name: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS; 8830 siempre viva rd #100; san diego CA 92154
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS; 8830 siempre viva rd #100; san diego CA 92154
• Manufacturer Contact: bryson heaton ; 1600 merit parkway; south jordan, UT 84095 ; 8012084662
• MDR Report Key: 15008293
• Report Number: 3011642792-2022-00019
• Device Sequence Number: 2316360
• Product Code: DRE
• UDI-Device Identifier: 00884450012680
• UDI-Public: 00884450012680
• Combination Product (Y/N): N
• Initial Reporter State: VT
• 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: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: 00884450012680
• Device Catalogue Number: MAK4F-10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2022
• Supplement Date Received by Manufacturer: 08/26/2022
• Initial Report FDA Received Date: 07/13/2022
• Supplement Report FDA Received Date: 09/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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