MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. WORLEY ADV. LVI.LATERAL VEIN INTRODUCER; INTRODUCER CATHETER

Catalog Number	WORLVI-75-5-62-55-RE
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
Event or Problem Description
The account alleges that during a cardiac resynchronization therapy (crt) procedure, a vein selector catheter tip detached within the patient.The physician had acquired successful antegrade venous access via the subclavian vein.A generator pocket was fashioned within the infraclavicular area parallel to the middle third of the patient's clavicle, the guidewire was then introduced under fluoroscopy, and the vein selector was introduced for targeted vein selection.The anterior lateral vessel was successfully selected.During manipulations for pacemaker lead purchase, the tip of the veinous selector detached within the patient's coronary sinus but remained on the guidewire.The physician successfully removed the foreign body from the patient with a 2mm coronary balloon.The crt procedure was successfully completed.No additional consequences to report.
Additional Manufacturer Narrative
The suspect device was returned for evaluation.The complaint was confirmed; however, the root cause could not be determined.Most probable cause is due to another device being introduced into the catheter and getting lodged.A search of the complaint database was performed and no similar complaints for this lot number were found.The device history record was reviewed, and no exception documents were found.

• Brand Name: WORLEY ADV. LVI.LATERAL VEIN INTRODUCER
• Common Device Name: INTRODUCER CATHETER
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 65 great valley pkwy; malvern PA 19355
• MDR Report Key: 11916467
• Report Number: 2032338-2021-00005
• Device Sequence Number: 4365128
• Product Code: DYB
• UDI-Device Identifier: 00884450284650
• UDI-Public: 884450284650
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K152116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2021

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: 01/31/2022
• Device Catalogue Number: WORLVI-75-5-62-55-RE
• Device Lot Number: Q1522071
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2021
• Initial Date Received by Manufacturer: 05/21/2021
• Supplement Date Received by Manufacturer: 07/29/2021
• Initial Report FDA Received Date: 06/01/2021
• Supplement Report FDA Received Date: 08/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDE CATHETER.; GUIDEWIRE .014.; GUIDE CATHETER; GUIDEWIRE .014
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention