MAUDE Adverse Event Report: MEDCOMP 4F X 13CM DBL. LUMEN CATHETER; INFUSION CATHETER

Model Number	MC2LP-313S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/17/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation has been initiated.We are currently waiting to determine if the device involved in the event is being returned for evaluation.When the investigation is complete a final report will be submitted.
Event or Problem Description
During passage of the catheter into the right femoral, the guidewire ruptured, with a need for a surgical procedure in the patient to remove the piece of material.
Additional Manufacturer Narrative
The device involved in the incident was not returned for evaluation.Attempts to obtain additional information about the device and event and to have the sample returned for evaluation were unsuccessful.The sample was discarded.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: 4F X 13CM DBL. LUMEN CATHETER
• Common Device Name: INFUSION CATHETER
• Manufacturer (Section D): MEDCOMP; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 6939882
• Report Number: 2518902-2017-00053
• Device Sequence Number: 1141051
• Product Code: DQY
• UDI-Device Identifier: 00884908028331
• UDI-Public: 884908028331
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K840175
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2018

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: 04/12/2021
• Device Model Number: MC2LP-313S
• Device Catalogue Number: MC2LP-313S
• Device Lot Number: MCAQ170
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/12/2017
• Supplement Date Received by Manufacturer: 09/12/2017
• Initial Report FDA Received Date: 10/11/2017
• Supplement Report FDA Received Date: 05/22/2018
• 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