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

Model Number	MR190411
Medical Device Problem Codes	Knotted (1340); Device Handling Problem (3265)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/19/2017
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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
• Common Device Name: MICRO-STICK INTRODUCER
• Manufacturer (Section D): MEDCOMP; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 6813951
• Report Number: 2518902-2017-00042
• Device Sequence Number: 18872688
• Product Code: DYB
• UDI-Device Identifier: 00884908085440
• UDI-Public: 884908085440
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2018

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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 07/28/2017
• Supplement Date Received by Manufacturer: 07/28/2017
• Initial Report FDA Received Date: 08/23/2017
• Supplement Report FDA Received Date: 04/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention