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

Model Number	MRCTT80041
Medical Device Problem Code	Wrinkled (2614)
Health Effect - Clinical Codes	Hemothorax (1896); Perforation (2001); Pneumothorax (2012)
Date of Event	11/09/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation has been initiated.When the investigation is complete a final report will be submitted.
Event or Problem Description
Restriction for venous dilation when passing the dilator due to damage of it.When advancing the dilator, the thickest sheath wrinkles, the thinnest dilator tears, so it is withdrawn and a new set of port is requested.New puncture is performed with good venous return but when passing the guidewire and under fluoroscopy verification, deviation of the guidewire to right thorax is noted.Patient refers thoracic pain.Thorax x-ray shows no evidence of pleural leak or pneumothorax but mediastinal enlargement; suspect of vascular lesion at subclavian/superior cava level.Insertion of port is canceled and urgent thorax and neck angiotomography is requested.Hemopneumothorax drain had to be performed with closed thoracotomy tube.

• Brand Name: 8F PRO-FUSE CT PORT
• Common Device Name: PRO-FUSE CT PORT
• Manufacturer (Section D): MEDCOMP; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 7161559
• Report Number: 2518902-2017-00071
• Device Sequence Number: 18856064
• Product Code: LJT
• UDI-Device Identifier: 00884908031393
• UDI-Public: 884908031393
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K132177
• 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): 10/12/2018

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: 12/30/2019
• Device Model Number: MRCTT80041
• Device Catalogue Number: MRCTT80041
• Device Lot Number: MGZA570
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/27/2017
• Supplement Date Received by Manufacturer: 12/27/2017
• Initial Report FDA Received Date: 01/03/2018
• Supplement Report FDA Received Date: 10/12/2018
• 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
• Patient Age: 48 YR