MAUDE Adverse Event Report: MEDCOMP 8F PRO-FUSE CT PORT

Model Number MRCTT80041

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Hemothorax (1896); Perforation (2001)

Event Date 05/12/2018

Event Type  Injury  

Manufacturer Narrative

Perforation is a known potential complication of the procedure identified in the instructions for use.

Event Description

Unique right subclavian puncture with no complications.Guidewire and dilator pass under seldinger.At that time patient presents left thoracic pain.X-ray reveal sheath and dilator has perforated the vein and we found left hemothorax with evidence of associated hemothorax.Thoracotomy tube was inserted and implantable catheter procedure canceled.

• Brand Name: 8F PRO-FUSE CT PORT
• Type of Device: PRO-FUSE CT PORT
• 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: 7686940
• MDR Text Key: 114009230
• Report Number: 2518902-2018-00044
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00884908031393
• UDI-Public: 884908031393
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K132177
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/29/2021
• Device Model Number: MRCTT80041
• Device Catalogue Number: MRCTT80041
• Device Lot Number: MJBQ370
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/2017
• 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): Required Intervention
• Patient Age: 73 YR