MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC MERIT CUSTOM KIT

Catalog Number K09-04816J

Device Problem Air Leak (1008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/23/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The account alleges that during a coronary angiography procedure, air was noticed leaking into the manifold from rotator connection.The air was successfully managed by the clinician throughout the procedure.No patient injury to report.

Manufacturer Narrative

The suspect device was 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 were found for this lot number.A review of the device history record was performed and no exception documents were found.

• Brand Name: MERIT CUSTOM KIT
• Type of Device: MERIT CUSTOM KIT
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC; 1600 merit parkway; south jordan UT 84095
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS INC; 1600 merit parkway; south jordan UT 84095
• Manufacturer Contact: casey hughes ms, cqe, csqp ; 1600 merit parkway; south jordan, UT 84095 ; 8013164932
• MDR Report Key: 6511059
• MDR Text Key: 73359593
• Report Number: 1721504-2017-00083
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 12/31/2019
• Device Catalogue Number: K09-04816J
• Device Lot Number: H1070553
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/19/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1