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

Catalog Number MAP400/A

Device Problem Air Leak (1008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/20/2017

Event Type  malfunction  

Manufacturer Narrative

The suspect device is not expected to return for evaluation.A follow up will be submitted when the evaluation is complete.

Event Description

The account alleges that air bubbles were seen inside the device during a percutaneous transluminal coronary angioplasty (ptca) procedure.No air was injected into the patient.A new device was used to complete the procedure.

Manufacturer Narrative

The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.A review of the complaint database was performed and no similar complaints for this lot number were found.A review of the device history record was performed and no exception documents were found.

• Brand Name: MBA 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: casey hughes, ms, cqe, csqp ; 1600 west merit parkway; south jordan, UT 84095
• MDR Report Key: 6593206
• MDR Text Key: 76035884
• Report Number: 9616662-2017-00019
• Device Sequence Number: 1
• Product Code: DTL
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/02/2017

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: 07/31/2019
• Device Catalogue Number: MAP400/A
• Device Lot Number: K1004480
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/02/2017
• Initial Date FDA Received: 05/25/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2016
• 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