MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC MINI ACCESS KIT

Catalog Number MAK501

Device Problems Material Fragmentation (1261); Material Separation (1562)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/04/2015

Event Type  malfunction  

Manufacturer Narrative

Device evaluation: no device is expected to be returned for evaluation.Because the unit was not returned, the root cause could not be determined.If the device is returned in the future this investigation will be reopened and a follow up submitted.Since the lot number was not provided, the device history record and complaint database could not be reviewed.

Event Description

A medwatch report was received stating that a portion of a wire separated from the shaft of the wire and was left in the patient.The part number is an estimate as no part number was provided.No contact information was provided with the report so no additional information could be obtained.

• Brand Name: MINI ACCESS KIT
• Type of Device: MINI ACCESS KIT
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC; 1600 west merit parkway; south jordan UT 84095
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS, INC; 1600 west merit parkway; south jordan UT 84095
• Manufacturer Contact: jerry mcphie ; 1600 west merit parkway; south jordan 84095 ; 8012084491
• MDR Report Key: 5381731
• MDR Text Key: 36654655
• Report Number: 1721504-2016-00013
• Device Sequence Number: 1
• Product Code: DRE
• Combination Product (y/n): N
• PMA/PMN Number: K031691
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial
• Report Date: 01/07/2016

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 Catalogue Number: MAK501
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/07/2016
• Initial Date FDA Received: 01/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1