MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. PRELUDE IDEAL HYDROPHILIC SHEATH INTRODUCER

Model Number	10884450317133
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	12/23/2020
Type of Reportable Event	Death
Additional Manufacturer Narrative
The suspect device is not expected to return for evaluation.A lot number was reported, and a review of the manufacturing history record is in progress.A follow up will be submitted when the evaluation is complete.
Event or Problem Description
The account alleges that a patient death occurred after the placement of an ideal sheath at (b)(6) hospital, (b)(6).The patient was to receive percutaneous cardiopulmonary support [pcps] due to a fatal condition, suspected to be caused by covid-19.The sheath was placed to infuse arterial blood into the patient's lower extremities to prevent lower-limb ischemia.On (b)(6) 2020, the ideal sheath access was attempted in an antegrade fashion via the right femoral artery.The patient developed a hematoma during access attempt.Manual compression was applied at the access site to control the hematoma with the access sheath still in place.Blood was also noted to be leaking from the base of the sheath hub due to a crack that was identified at the strain relief portion of the sheath.At an unknown time after this event, the patient expired.Cause of patient death has not been confirmed.The complaint sample will not be returning because of the suspected patient infection.(b)(4) is trying to track down the physician for additional information.A good faith effort of 3 or more attempts to collect additional information regarding this event from this account has been successfully completed in a timely manner.No additional information about this event has been provided to merit medical.
Additional Manufacturer Narrative
The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.Should the device return at a later date, the investigation will be re-opened.

• Brand Name: PRELUDE IDEAL HYDROPHILIC SHEATH INTRODUCER
• Common Device Name: SHEATH INTRODUCER
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan UT 84095
• MDR Report Key: 11135947
• Report Number: 1721504-2021-00001
• Device Sequence Number: 17154365
• Product Code: DYB
• UDI-Device Identifier: 10884450317133
• UDI-Public: 10884450317133
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K173750
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2020

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: 12/31/2022
• Device Model Number: 10884450317133
• Device Catalogue Number: PID7F16021PW
• Device Lot Number: H1912858
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/23/2020
• Supplement Date Received by Manufacturer: 01/20/2021
• Initial Report FDA Received Date: 01/07/2021
• Supplement Report FDA Received Date: 01/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Required Intervention