MAUDE Adverse Event Report: MEDCOMP 4FX55CM SGL PRO PICC CT-BASIC; PRO-PICC CT

Model Number	MR17034101
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/12/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
During placement of the picc, a knot arose in the guidewire.The vessel was smoothly punctured and the guidewire introduced, initially taking the jugular pathway.The guidewire curled back in several directions and eventually a knot arose.The wire got stuck in the vein approximately 10 cm proximal from the puncture side.The wire was eventually pulled from the vessel, causing damage to the basilica vein a new guidewire and dilator were opened and used to place the picc in another vein.
Additional Manufacturer Narrative
One 0.018" guidewire was received for evaluation.A visual examination of the device confirmed the report.The guidewire has a knot approximately 1/2" from the distal end.The root cause for this incident could not be determined.The report indicated that there was difficulty during the procedure navigating the wire to the superior vena cava.During this the guidewire curled back in several directions.The technique used caused the tip of the wire to loop over itself and become knotted preventing removal.This type of event has been well documented in the literature when difficult insertions occur.

• Brand Name: 4FX55CM SGL PRO PICC CT-BASIC
• Common Device Name: PRO-PICC CT
• Manufacturer (Section D): MEDCOMP; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 8398444
• Report Number: 2518902-2019-00014
• Device Sequence Number: 19346351
• Product Code: LJS
• UDI-Device Identifier: 00884908033069
• UDI-Public: 884908033069
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2019

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 Model Number: MR17034101
• Device Catalogue Number: MR17034101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/05/2019
• Supplement Date Received by Manufacturer: 02/05/2019
• Initial Report FDA Received Date: 03/07/2019
• Supplement Report FDA Received Date: 06/05/2019
• 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: 57 YR