MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS MEXICO SAFESHEATH® WORLEY LEAD DELIVERY CATHETER; LATERAL VEIN INTRODUCER CATHETER

Catalog Number	FCL-137-02/A
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/30/2023
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 biventricular pacemaker/ implantable cardioverter defibrillator (biv-icd) implant procedure, the vein selector tip detached within the patient's coronary sinus.A vascular snare was unsuccessfully used in an attempt to remove the foreign body.The foreign body was left within the patient.Another device was used to complete the procedure.No additional patient consequences to report.The patient is stable and asymptomatic.
Additional Manufacturer Narrative
The suspect device was not returned for evaluation.The complaint could not be confirmed and a root cause could not be determined.A review of the device history record was performed and one similar complaint was identified for this lot number.The similar complaint is still under investigation at this time.

• Brand Name: SAFESHEATH® WORLEY LEAD DELIVERY CATHETER
• Common Device Name: LATERAL VEIN INTRODUCER CATHETER
• 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: 16717130
• Report Number: 3011642792-2023-00024
• Device Sequence Number: 15272462
• Product Code: DYB
• UDI-Device Identifier: 00884450483749
• UDI-Public: 884450483749
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K120158
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2023

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: 02/22/2024
• Device Catalogue Number: FCL-137-02/A
• Device Lot Number: I2053630
• 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: 03/30/2023
• Supplement Date Received by Manufacturer: 07/26/2023
• Initial Report FDA Received Date: 04/11/2023
• Supplement Report FDA Received Date: 07/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2021
• 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; INTRODUCER CATHETER
• Outcome Attributed to Adverse Event: Life Threatening; Hospitalization; Required Intervention
• Patient Sex: Unknown