MAUDE Adverse Event Report: MERIT MEDICAL IRELAND LTD. HONOR HEMOSTASIS VALVE

Catalog Number MAP352

Device Problem Air Leak (1008)

Patient Problem Cardiac Arrest (1762)

Event Date 11/05/2015

Event Type  malfunction  

Manufacturer Narrative

Device evaluation.The affected device was discarded by the user and is not expected to be returned.The evaluation is in process.A follow up report will be submitted when the evaluation has been completed.

Event Description

The user reported that during a cardiac procedure air was introduced into the system through the hemostasis valve.The air was found before it was injected into the patient.No harm or injury to the patient was reported.

Manufacturer Narrative

One device was returned for evaluation.A leak could only be reproduced at vacuum levels exceeding the product's specification.The complaint was unable to be confirmed when operating the device per the instructions for use.The device history record was reviewed and no exception documents were found.The complaint database was reviewed and no similar complaints for this lot number were found.

• Brand Name: HONOR HEMOSTASIS VALVE
• Type of Device: HEMOSTASIS VALVE
• Manufacturer (Section D): MERIT MEDICAL IRELAND LTD.; parkmore industrial estate; galway, ; EI
• Manufacturer (Section G): MERIT MEDICAL IRELAND LTD.; parkmore industrial estate; galway, ; EI
• Manufacturer Contact: jerry mcphie ; 1600 west merit parkway; south jordan 84095 ; 8012084491
• MDR Report Key: 5262920
• MDR Text Key: 32579479
• Report Number: 9616662-2015-00020
• Device Sequence Number: 1
• Product Code: DTL
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K042060
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/05/2015

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
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2018
• Device Catalogue Number: MAP352
• Device Lot Number: K806876
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/05/2015
• Initial Date FDA Received: 12/03/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/09/2015
• 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