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

Catalog Number	S-MAK401N/C
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/18/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device has returned for merit evaluation.A follow-up report will be submitted once the evaluation is complete.
Event or Problem Description
The account alleges that during a left superior femoral and tibial artery angioplasty procedure on a 79yo patient, 2cm of hydrophilic coating may have detached from the micropuncture access sheath and was retained within the patient's common iliac artery.The patient became severely bradycardic during this procedure, so the procedure was canceled.
Additional Manufacturer Narrative
The suspect medical device was returned for evaluation.The complaint is confirmed.The root cause could not be determined however, it is likely that significant force was applied to the device during clinical use.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.

• Brand Name: MERIT S-MAK¿
• Common Device Name: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• 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: 16908518
• Report Number: 3011642792-2023-00033
• Device Sequence Number: 12136818
• Product Code: DRE
• UDI-Device Identifier: 00884450012635
• UDI-Public: 884450012635
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Foreign,Study,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2023

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: S-MAK401N/C
• Device Lot Number: I2496594
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2023
• Supplement Date Received by Manufacturer: 06/13/2023
• Initial Report FDA Received Date: 05/10/2023
• Supplement Report FDA Received Date: 06/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/31/2022
• 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 ACCESS GUIDWIRE.
• Patient Sex: Unknown