MAUDE Adverse Event Report: MEDCOMP 5.5FX5CM TEARAWAY INTRO SET; TEARAWAY INTRODUCER

Model Number MR190505

Device Problems Knotted (1340); Difficult to Remove (1528)

Patient Problem No Information (3190)

Event Date 08/27/2015

Event Type  Injury  

Event Description

Guidewire was introduced through introducer needle in right jugular vein, echo-guided; noted high resistance to removal.Surgery was required to remove the guidewire which was knotted about 1 cm from distal part.

Manufacturer Narrative

A 0.18' guide wire was received with needle attached for evaluation.A visual inspection showed the guide wire to be still inserted in the needle.The guide wire had become slightly unraveled and there is knot in the end of the guidewire.An undamaged section of the wire was measured and found to conform to the dimensional specifications.The wire would not have been used if it was in this condition prior to insertion.We are unable to determine the exact cause however it appears that the wire became knotted in the subcutaneous tissue or vessel during the insertion attempt.

• Brand Name: 5.5FX5CM TEARAWAY INTRO SET
• Type of Device: TEARAWAY 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: 5113449
• MDR Text Key: 27099366
• Report Number: 2518902-2015-00078
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 02/04/2016

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?: No
• Device Operator: Other
• Device Expiration Date: 03/03/2020
• Device Model Number: MR190505
• Device Catalogue Number: MR190505
• Device Lot Number: MBXH830
• Other Device ID Number: 884908033700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2015
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 09/04/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/30/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2015
• 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