MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. SAFESHEATH® WORLEY¿ LVI; INTRODUCER, CATHETER

Catalog Number FCL-137-00

Device Problem Difficult to Remove (1528)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/07/2021

Event Type  Injury  

Manufacturer Narrative

The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.

Event Description

The account alleges that during a crtd procedure, while attempting to remove the sheath, they were unable to remove the entire sheath due to strong resistance.The clinican cut the sheath with a scalpel leaveing one part of the sheath on the electrode and the other remained inside the patient's vein.The procedure was reported to be completed with no additional patient consequence to report.

Manufacturer Narrative

The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.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: SAFESHEATH® WORLEY¿ LVI
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 65 great valley pkwy; malvern PA 19355
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS INC.; 65 great valley pkwy; malvern PA 19355
• Manufacturer Contact: bryson heaton ; 1600 merit parkway; south jordan, UT 84095
• MDR Report Key: 13177577
• MDR Text Key: 283323431
• Report Number: 3011642792-2022-00001
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00884450162286
• UDI-Public: 884450162286
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120158
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Catalogue Number: FCL-137-00
• Device Lot Number: Q1536806
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1