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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The account alleges that during a biventricular pacemaker/ implantable cardioverter defibrillator (biv-icd) implant procedure, the vein selector tip became wedged and detached within the patient's right atrium.A vascular snare device was successfully used to remove the foreign body.Another device was used to complete the procedure for this patient.No additional patient consequences to report.
Additional Manufacturer Narrative
The suspect medical device has returned for an evaluation.A follow-up report will be submitted once the evaluation is complete.
Additional Manufacturer Narrative
The suspect medical device has been returned for evaluation.The device was visually and microscopically investigated.The complaint is confirmed.The root cause is attributed to environmental conditions during device storage.The device history record was reviewed, and no exception documents were found.A search of the complaint database was performed and only one additional complaint for this lot number was identified.

• 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: 16717217
• Report Number: 3011642792-2023-00025
• Device Sequence Number: 13856670
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2023
• 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: 08/14/2023
• Initial Report FDA Received Date: 04/11/2023
• Supplement Report FDA Received Date: 08/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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