MAUDE Adverse Event Report: PRODUCTOS MEDLINE, S.A. DE C.V.; LEFT HEART KIT

Catalog Number	VASC1131
Health Effect - Clinical Codes	Death (1802); Therapeutic Response, Decreased (2271)
Date of Event	10/24/2020
Type of Reportable Event	Death
Additional Manufacturer Narrative
It was reported that on (b)(6) 2020 the transducer seal failed and drew air in during a case which almost injected air into a patient.The clinician reportedly had to change out the device during an st-elevation myocardial infarction (stemi) after experiencing manifold failures twice during the same procedure requiring replacement and pause, delaying patient care in progress.Ultimately the case had to cease due to the patient coding and expiring.No additional details are available related to the customer reported issue.The customer contact was unwilling to provide further incident details to the manufacturer.No sample was returned for evaluation.No additional information is available.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
It was reported that the transducer seal failed and drew air in during a procedure requiring replacement of the device and delaying patient care.

• Common Device Name: LEFT HEART KIT
• Manufacturer (Section D): PRODUCTOS MEDLINE, S.A. DE C.V.; blvd. world trade center no. 1; parque industrial oradel; nuevo laredo, tamaulipas 88285 ; MX 88285
• MDR Report Key: 10825226
• Report Number: 3004122598-2020-00008
• Device Sequence Number: 13731742
• Product Code: OEZ
• UDI-Device Identifier: 10889942854325
• UDI-Public: 10889942854325
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/11/2020

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: VASC1131
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/26/2020
• Initial Report FDA Received Date: 11/11/2020
• 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