MAUDE Adverse Event Report: MEDCOMP 14 GA. X 5 1/4 FEMORAL CATHETER; HEMODIALYSIS CATHETER

Model Number	MCF64
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/23/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device involved in the incident was not returned for evaluation.A picture of the device was provided and the customer indicated on the picture that the device lumen separated from the hub.The complaint information was forwarded to the device contract manufacturer for evaluation.
Event or Problem Description
This report involves a gentleman who had a straight femoral catheter inserted for vascular access.The femoral vein was cannulated and a guide wire was passed with ease.The catheter was threaded over the guide wire.As the guide wire was removed, the thermoplastic leur lock which is the external element of the catheter got detached from the catheter sheath leaving the catheter buried inside the body.Imaging with an xray and ultrasound showed the position of the catheter in the femoral vein.This gentleman required a deep exploration to be done by a vascular surgeon for retrieval of the catheter.
Additional Manufacturer Narrative
Based on review of the device history record and process review, the product was manufactured in accordance with specifications.Without an evaluation of the device the root cause could not be determined.

• Brand Name: 14 GA. X 5 1/4 FEMORAL CATHETER
• Common Device Name: HEMODIALYSIS CATHETER
• Manufacturer (Section D): MEDCOMP; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 8090846
• Report Number: 2518902-2018-00060
• Device Sequence Number: 1437787
• Product Code: MSD
• UDI-Device Identifier: 00884908026757
• UDI-Public: 884908026757
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: 07
• 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,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2019

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?: Yes
• Operator of Device: Other
• Device Expiration Date: 03/15/2022
• Device Model Number: MCF64
• Device Catalogue Number: MCF64
• Device Lot Number: MCDF410
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/26/2018
• Supplement Date Received by Manufacturer: 10/26/2018
• Initial Report FDA Received Date: 11/20/2018
• Supplement Report FDA Received Date: 03/07/2019
• 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
• Patient Age: 60 YR
• Patient Weight: 58