MAUDE Adverse Event Report: MERIT MEDICAL IRELAND LTD. MERIT CUSTOM KIT

Catalog Number K12T-07796C

Device Problem Air Leak (1008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/02/2017

Event Type  malfunction  

Manufacturer Narrative

The device has been returned for evaluation.A follow up will be submitted when evaluation is complete.

Event Description

Account alleges that during a coronary intervention air was introduced into the system where the transducer connects to the manifold during aspiration.

Manufacturer Narrative

The suspect device was returned for evaluation.The device was examined visually.The complaint is confirmed.The root cause could not be confirmed.However, it is likely that the unit was dropped or struck while debubbling for the procedure.A review of the complaint database and device history record could not be completed since the lot number was not provided.

• Brand Name: MERIT CUSTOM KIT
• Type of Device: MERIT CUSTOM KIT
• Manufacturer (Section D): MERIT MEDICAL IRELAND LTD.; parkmore industrial estate; ballybrit, ; EI
• Manufacturer (Section G): MERIT MEDICAL IRELAND LTD.; parkmore industrial estate; ballybrit, ; EI
• Manufacturer Contact: casey hughes ms, cqe ; avenido sor juana ines de la c; #19970-b; colonia parque industrial laf, 19970 ; MX 19970
• MDR Report Key: 6414388
• MDR Text Key: 70323489
• Report Number: 9616662-2017-00010
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K913682
• 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: 02/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: K12T-07796C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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