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

Catalog Number K12T-02036J

Device Problems Detachment Of Device Component (1104); Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/22/2016

Event Type  Injury  

Manufacturer Narrative

The suspect device was returned for evaluation.A follow up will be submitted when the investigation is complete.

Event Description

The user reported that during initial insertion the wire unraveled and a piece less than 1/2 cm in length separated in a small collateral branch of the basilic vein.The physician was unable to retrieve the fragment.No further injuries were reported.

Manufacturer Narrative

One device was returned for evaluation.The product was examined visually.The complaint is confirmed.No definitive root cause could be determined.A review of the device history and complaint data base could not be reviewed since the lot number was not provided.

• Brand Name: MERIT CUSTOM KIT
• Type of Device: CUSTOM KIT
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC; 12701 kingston ave; chester VA 23836
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS, INC; 12701 kingston ave; chester VA 23836
• Manufacturer Contact: casey hughes, ms, cqe ; 1600 west merit parkway; south jordan, UT 84095 ; 8013164932
• MDR Report Key: 5888621
• MDR Text Key: 52512284
• Report Number: 1125782-2016-00016
• 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: 07/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: K12T-02036J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/25/2016
• Initial Date FDA Received: 08/19/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/24/2017
• 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
• Patient Outcome(s): Life Threatening; Required Intervention