MAUDE Adverse Event Report: MEDCOMP 4F STIFF MICRO-STICK NIT WIRE KIT; MICRO-STICK INTRODUCER

Model Number MR190411

Device Problems Knotted (1340); Device Handling Problem (3265)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/19/2017

Event Type  malfunction  

Manufacturer Narrative

We are currently waiting for the return of the device sample for evaluation.Once received the investigation will proceed and when completed a final report will be submitted.

Event Description

At the time the guidewire was being introduced it got stuck and it didn't advance.When they managed to take it out, they saw there was a knotted in it at the tip of the wire.

Manufacturer Narrative

Received a.018" guidewire and 4f microstick for evaluation.A visual inspection revealed a the guidewire through the microstick with a knot at the tip of the guidewire preventing removal of the microstick.The device was forwarded to the device manufacturer for inspection.Based on the investigation performed, it was determined that product was manufactured to specifications at this time.Previous investigations by the device manufacturer stated that possible contributing factors to the event may have been resistance in the guidewire during insertion and/or the patient's anatomy.The incident report said that the guidewire got stuck and didn't advance.The instructions for use state "do not advance the guidewire or catheter if unusual resistance is encountered".

• Brand Name: 4F STIFF MICRO-STICK NIT WIRE KIT
• Type of Device: MICRO-STICK INTRODUCER
• Manufacturer (Section D): MEDCOMP; 1499 delp drive; harleysville PA 19438
• Manufacturer (Section G): MEDCOMP; 1499 delp drive; harleysville PA 19438
• Manufacturer Contact: 1499 delp drive; harleysville, PA 19438 ; 2152564201
• MDR Report Key: 6813951
• MDR Text Key: 83473764
• Report Number: 2518902-2017-00042
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00884908085440
• UDI-Public: 884908085440
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/25/2022
• Device Model Number: MR190411
• Device Catalogue Number: MR190411
• Device Lot Number: MJBS030
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/28/2017
• Date Device Manufactured: 02/01/2017
• 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