MAUDE Adverse Event Report: PFM MEDICAL, INC. PRIMEPICC OR PRIMEMIDLINE; INTRAVASCULAR CATHETER

Model Number UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problem Vessel Or Plaque, Device Embedded In (1204)

Event Date 11/27/2018

Event Type  Injury  

Manufacturer Narrative

3 good faith attempts were made to the reporter to get additional information about the device (i.E.Ref, lot number).Reporter did not respond to the requests.Reporter did additionally mention that the guidewire was only advanced 8 to 10 cm into the vessel and noticed it wouldn't pull back.The guidewire appeared to be unravelling.The aguidewire is sourced from another supplier and are unable to determine which guidewire as the exact product used has not been provided.

Event Description

Picc or midline was being placed and guidewire was unable to be removed through sheath dilator including multiple attempts following partial removal of dilator.Guidweire was left in place and patient referred to interventional radiology dept.

• Brand Name: PRIMEPICC OR PRIMEMIDLINE
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): PFM MEDICAL, INC.; 1916 palomar oaks way; suite 150; carlsbad CA 92008
• Manufacturer Contact: troy taylor ; 1916 palomar oaks way; suite 150; carlsbad, CA 92008 ; 7607588749
• MDR Report Key: 8228559
• MDR Text Key: 132541285
• Report Number: 2032582-2018-00007
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• PMA/PMN Number: K072391
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/08/2019

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?: No
• Device Operator: Other
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/27/2018
• Initial Date FDA Received: 01/08/2019
• 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): Required Intervention