MAUDE Adverse Event Report: MEDCOMP 5FX60CM DUAL LMN VASCU-PICC

Model Number	MR17015205
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/17/2018
Type of Reportable Event	Malfunction
Event or Problem Description
During the insertion the guidewire got stuck.When removed the tip of the wire was noted to be knotted.
Additional Manufacturer Narrative
The device involved in the incident was not returned for evaluation.A picture of the device was provided and confirmed the tip of the guidewire is knotted.Without an evaluation of the device we are unable to determine the root cause and if a manufacturing issue was present.A possible cause for this type of event is manipulation of the guidewire (advancing and pull back on the wire) during the insertion procedure.This technique may cause the tip of the wire to loop over itself and become knotted preventing removal and ultimately causing the wire to break and unravel.This is well documented in the literature.

• Brand Name: 5FX60CM DUAL LMN VASCU-PICC
• Common Device Name: VASCU-PICC
• Manufacturer (Section D): MEDCOMP; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 7893921
• Report Number: 2518902-2018-00052
• Device Sequence Number: 2508252
• Product Code: LJS
• UDI-Device Identifier: 00884908083460
• UDI-Public: 884908083460
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2019

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
• Operator of Device: Other
• Device Expiration Date: 05/16/2021
• Device Model Number: MR17015205
• Device Catalogue Number: MR17015205
• Device Lot Number: MLHP030
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/23/2018
• Supplement Date Received by Manufacturer: 08/23/2018
• Initial Report FDA Received Date: 09/20/2018
• Supplement Report FDA Received Date: 06/04/2019
• 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