MAUDE Adverse Event Report: MEDCOMP 5F STIFF MICRO STICK; GUIDEWIRE

Model Number MR190511

Device Problems Cut In Material (2454); Detachment of Device or Device Component (2907)

Patient Problem No Code Available (3191)

Event Date 02/28/2014

Event Type  Injury  

Event Description

During initial access of artery using a micro puncture needle and wire set, the tip of wire was shaved off and left in pt.Using another product and company equivalent the same event happened and a second tip was shaved off and left in pt.Surgically removed.

Manufacturer Narrative

The device involved in the incident was not returned for eval.W/o an eval of the device involved, we are unable to determine the cause or factors that may have contributed to this event.

• Brand Name: 5F STIFF MICRO STICK
• Type of Device: GUIDEWIRE
• Manufacturer (Section D): MEDCOMP; harleysville PA
• Manufacturer (Section G): MEDCOMP; 1499 delp dr.; harleysville PA 19438
• Manufacturer Contact: susan smith, rn ; 1499 delp dr.; harleysville, PA 19438 ; 2152564201
• MDR Report Key: 3814913
• MDR Text Key: 4525375
• Report Number: 2518902-2014-00031
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/06/2014,05/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2016
• Device Model Number: MR190511
• Device Catalogue Number: MR190511
• Device Lot Number: MBSL250
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/06/2014
• Distributor Facility Aware Date: 04/03/2014
• Date Manufacturer Received: 04/03/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/24/2013
• 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): Required Intervention