MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS MEXICO SPLITTABLE SHEATH INTRODUCER.; INTRODUCER, CATHETER

Catalog Number	PLS-1008/A
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2022
Type of Reportable Event	Death
Additional Manufacturer Narrative
The suspect device is not expected to return for evaluation.A lot number has been provided and a review of the manufacturing history record is in progress.
Event or Problem Description
The account alleges that post- cardiac resynchronization therapy-defibrillator [crt-d] implant procedure, the patient expired in the recovery unit.The physician alleges that at the beginning of the crt-d implant case, the stopcock on the sheath introducer was in the open position and air was noted within the tubing of the introducer sheath.The device was still used for access during the case and anesthesia stabilized the patient during the procedure.The physician alleges that air may have been introduced into the patient's subclavian vein and migrated during sheath placement.The patient would not stop coughing at times during the procedure, and o2 saturations had dropped.The crt-d device was successfully implanted and tested.All pacing parameters had been set correctly and the defibrillator was capturing as intended.The crt-d implant procedure was successfully completed.The patient was transferred to a recovery unit for observation in stable condition.The patient expired at some time during recovery.The cause of death is unknown.A hospital investigation is currently underway.The device was discarded and will not be returned for manufacturer evaluation.
Additional Manufacturer Narrative
According with the summary reported by the customer, the physician was notified by the attending medical device representatives that all introducer sheaths are packaged and shipped with the t-valve [stopcock] in the closed position, and if the valve was left in the open position after prepping the device, it would have been the responsibility of the clinical staff prepping the device or using the device to close the valve before using the sheath for procedures.The valve was inadvertently left in the open position after the device was prepped.Adverse event related to use error.

• Brand Name: SPLITTABLE SHEATH INTRODUCER.
• Common Device Name: 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: 15990692
• Report Number: 3011642792-2022-00112
• Device Sequence Number: 6103024
• Product Code: DYB
• UDI-Device Identifier: 00884450467992
• UDI-Public: 884450467992
• Combination Product (Y/N): N
• PMA/510(K) Number: K143255
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/03/2025
• Device Catalogue Number: PLS-1008/A
• Device Lot Number: I2220851
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2022
• Supplement Date Received by Manufacturer: 01/25/2023
• Initial Report FDA Received Date: 12/15/2022
• Supplement Report FDA Received Date: 01/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/19/2021
• 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: CRT-D LEADS.
• Outcome Attributed to Adverse Event: Death
• Patient Age: 81 YR
• Patient Sex: Female