MAUDE Adverse Event Report: DEYROYAL INTERCONTINENTAL, S.R.L.,; LEFT HEART KIT - HILL

Catalog Number	VASC1165
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Email received by facility representative of (b)(6), with additional information related to this incident.Reporter states this incident occurred on (b)(6) 2020.Reporter states, "the lines and manifold were all cleared of air prior to the procedure starting and then again prior to injection of the contrast into the coronaries.The patient complained of mild chest discomfort at that time." reporter states, "the manifold was replaced with a product from a different manufacturer, causing a delay in the procedure while the patient was assessed and the change of product took place." reporter states, "no serious injury identified based on patient symptomology.No medical intervention required." reporter states patient has been seen in the office for follow up care and "seems to be doing well." the sample has not been returned for evaluation.Due to the nature of the reported incident and in abundance of caution, this medwatch is being filed.No further information is available at this time.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
It has been reported, "the manifold (part of left heart kit) leaks."air bubbles were injected into a patient's coronary artery.".

• Common Device Name: LEFT HEART KIT - HILL
• Manufacturer (Section D): DEYROYAL INTERCONTINENTAL, S.R.L.,; km 7, autopista joaquin balagu; santiago, santiago 1234 DO; DR 1234 DO
• MDR Report Key: 10770308
• Report Number: 3015910259-2020-00002
• Device Sequence Number: 3595250
• Product Code: DTL
• UDI-Device Identifier: 10889942955886
• UDI-Public: 10889942955886
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: VASC1165
• Device Lot Number: 19GBW672
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/06/2020
• Initial Report FDA Received Date: 11/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1