MAUDE Adverse Event Report: MEDCOMP 14F X 40CM SPLIT CATH III; SPLIT CATH III HEMODIALYSIS CATHETER

Model Number ASPC40-3

Device Problems Failure to Advance (2524); Physical Resistance (2578)

Patient Problems Death (1802); Erythema (1840); Exsanguination (1841); Perforation (2001)

Event Date 01/05/2017

Event Type  Death  

Manufacturer Narrative

An investigation has been initiated.The user facility has been contacted and additional information has been requested.When the investigation is completed, a final report will be submitted.

Event Description

Perforation during catheter exchange.

Manufacturer Narrative

The incident occurred in (b)(6) 2017.Medcomp was not made aware of this event until september 2017, by the fda.Upon notification of the incident medcomp immediately contacted the user facility to determine if the device(s) or additional information regarding the event were available.The risk manager replied the device was not retained and the description of the event is in the report.No further details were offered.Without a device to evaluate the investigation was conducted by evaluating the event description.The report indicated the dilator and peel-away sheath which came with the kit were used with a "stiff angled glidewire" which is not a medcomp product and is not included with the kit.From the event description it was concluded that this was not a product issue, it was a procedural issue.The instructions for use for this device include the following potential complications for the insertion procedure: hemorrhage, hemothorax, mediastinal injury, perforation of the vessel, pneumothorax.The instructions for use also includes the following warnings: "do not advance the guidewire or catheter if unusual resistance is encountered" and "do not insert or withdraw the guidewire forcibly from any component.".

• Brand Name: 14F X 40CM SPLIT CATH III
• Type of Device: SPLIT CATH III HEMODIALYSIS CATHETER
• 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: 6887920
• MDR Text Key: 87153063
• Report Number: 2518902-2017-00050
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 00884908004205
• UDI-Public: 884908004205
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051280
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2017
• Is this an Adverse Event Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/29/2019
• Device Model Number: ASPC40-3
• Device Catalogue Number: ASPC40-3
• Device Lot Number: MHWB960
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/15/2017
• Event Location: Hospital
• Date Manufacturer Received: 09/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2016
• 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): Death