MAUDE Adverse Event Report: MEDCOMP 15.5F X 15CM IJ ST FREE FLOW; ST FREE-FLOW

Model Number JFFS1515IJ

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Low Blood Pressure/ Hypotension (1914); Perforation (2001); Cardiac Tamponade (2226); Malaise (2359)

Event Type  Death  

Event Description

The patient was unwell, blood pressure dropped, no more approachable after cpr was performed.The cardiac tamponade was not (timely) observed.At the time of resuscitation there was no indication that the catheter could be the issue.The insertion procedure was performed adequately.Only at autopsy, there appeared a very small hole in the pericardium to be seated which can (.) indicate the damage of the heart wall by the guide wire.That is nowhere confirmed.

Manufacturer Narrative

Perforation is a known potential complication that can occur during the insertion procedure and is included in the instructions for use.

• Brand Name: 15.5F X 15CM IJ ST FREE FLOW
• Type of Device: ST FREE-FLOW
• 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: 5108401
• MDR Text Key: 26935505
• Report Number: 2518902-2015-00076
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K040328
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 09/03/2015,11/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: JFFS1515IJ
• Device Catalogue Number: JFFS1515IJ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 09/03/2015
• Date Report to Manufacturer: 09/03/2015
• Date Manufacturer Received: 09/03/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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