MAUDE Adverse Event Report: MEDCOMP 8F X 18CM HEMO-CATH; HEMO-CATH HEMODIALYSIS CATHETER

Model Number	SL18P
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	12/13/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation has been initiated.When the investigation is complete a supplemental report will be submitted.
Event or Problem Description
During catheter exchange the catheter broke at the hub and had to be retrieved through the groin access.The catheter has been in place for approximately three months.During the retrieval procedure, the new catheter broke.All pieces were eventually removed from the patient.
Additional Manufacturer Narrative
The device involved in the incident was not returned for evaluation.Attempts to obtain additional information and a sample for evaluation were unsuccessful.Without sufficient information, or an evaluation of the device involved, we are unable to determine the cause or factors that may have contributed to this event.

• Brand Name: 8F X 18CM HEMO-CATH
• Common Device Name: HEMO-CATH HEMODIALYSIS CATHETER
• Manufacturer (Section D): MEDCOMP; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 6335732
• Report Number: 2518902-2017-00006
• Device Sequence Number: 885698
• Product Code: MSD
• UDI-Device Identifier: 00884908045444
• UDI-Public: 884908045444
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2016
• Reporter Type: User Facility
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2017

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 Model Number: SL18P
• Device Catalogue Number: SL18P
• Device Lot Number: MCCB030
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/16/2017
• Supplement Report FDA Received Date: 05/01/2017
• 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: 3 YR