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

Catalog Number K12T-07796D

Device Problem Air Leak (1008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/19/2017

Event Type  malfunction  

Manufacturer Narrative

The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.

Event Description

The account alleged that there was a leakage of air into the manifold during a percutaneous coronary intervention [pci].No injury to the patient was reported.

Manufacturer Narrative

The suspect device was returned for evaluation.The device was examined visually and tested.The complaint is unconfirmed.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: MERIT CUSTOM KIT
• Type of Device: CUSTOM KIT
• 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: 6675626
• MDR Text Key: 78702512
• Report Number: 9616662-2017-00025
• 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: 06/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2019
• Device Catalogue Number: K12T-07796D
• Device Lot Number: K1107396
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/09/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1