MAUDE Adverse Event Report: PFM MEDICAL, INC. PRIMEPICC; PERIPHERALLY INSERTED CENTRAL CATHETER

Model Number	PFM2CT5D
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Vessel Or Plaque, Device Embedded In (1204); Discomfort (2330)
Date of Event	07/17/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Dhr review performed and no contributing factors were found for the issue.The guidewire is a component of the end product and is not manufactured by pfm medical, inc.The product and component had no associated non-conformances or similar issues reported.No further investigation possible without the device returned.Reporter check in with the vascular surgeon multiple times to see how the patient was doing.
Event or Problem Description
Issue with a guide wire in which resulted in the patient having to be sent to ir for removal.After obtaining access to the vein without issue, the guidewire was inserted.The guidewire was only able to be inserted 6-10 cm in.An attempt to remove the guidewire was made but was not successful.The needle was removed and a second attempt was made to remove the guidewire puling the line gently, however it began to fray and come unraveled.The ultrasound was used to visualize the guidewire and showed it inside the vessel but appeared to have developed a knot at the end.An incision was created and the introducer inserted to try to create a larger opening for the guidewire.This was unsuccessful.The wire was then coiled, the insertion site dressed, and the md was notified.

• Brand Name: PRIMEPICC
• Common Device Name: PERIPHERALLY INSERTED CENTRAL CATHETER
• Manufacturer (Section D): PFM MEDICAL, INC.; 1916 palomar oaks way; suite 150; carlsbad CA 92008
• MDR Report Key: 7878827
• Report Number: 2032582-2018-00003
• Device Sequence Number: 16621398
• Product Code: LJS
• UDI-Device Identifier: 00813623013728
• UDI-Public: 00813623013728
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K083873
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/14/2018

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2019
• Device Model Number: PFM2CT5D
• Device Catalogue Number: PFM2CT5D
• Device Lot Number: 1708-006
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2018
• Initial Report FDA Received Date: 09/14/2018
• 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