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

Model Number	ASPC40-3
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance (2578)
Health Effect - Clinical Codes	Death (1802); Erythema (1840); Exsanguination (1841); Perforation (2001)
Date of Event	01/05/2017
Type of Reportable Event	Death
Additional 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 or Problem Description
Perforation during catheter exchange.
Additional 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
• Common Device Name: SPLIT CATH III HEMODIALYSIS CATHETER
• Manufacturer (Section D): MEDCOMP; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 6887920
• Report Number: 2518902-2017-00050
• Device Sequence Number: 19037440
• Product Code: MSD
• UDI-Device Identifier: 00884908004205
• UDI-Public: 884908004205
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K051280
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: User Facility
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: 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
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/15/2017
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/15/2017
• Initial Report FDA Received Date: 09/22/2017
• Supplement Report FDA Received Date: 10/07/2017
• 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: Death