MAUDE Adverse Event Report: PFM MEDICAL, INC. PRIMEMIDLINE; MIDLINE CATHETER

Model Number PFM4SML20P (SIMILAR TO PFM4SML20)

Device Problems Entrapment of Device (1212); Stretched (1601)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/29/2023

Event Type  malfunction  

Manufacturer Narrative

A device history review (dhr) was performed and no deviations were found.Inspection of the product retain (ln 2007-040) was performed, it was confirmed that the guide-wire met all listed requirements as outlined in the specification.The information provided was used to conduct an investigation on the product retain.During the investigation, the described error characteristic could not be duplicated.The retain guidewire was able to advance through the introducer needle without restriction.Upon arrival, the return sample was analyzed.Based off the visual evidence it is believed that the damage was due to operator error during the insertion of the guidewire.The information provided indicates that prior to inserting the guidewire, the operator had difficulty placing the introducer needle as they stated the "vein was very compressible".After flash back was observed, the operator passed the guidewire through the introducer needle at which time resistance was noticed.Although flashback was observed it is possible for the introducer needle was not properly placed into the lumen and was still in the media or intima of the vein.This would account for the noticeable resistance observed with placing the guidewire.Upon noticing the resistance the operator proceeded by trying to withdraw the guidewire.Per the ifu (ls-ga061-01-ab) if the guidewire must be withdrawn while the needle is inserted, remove both the needle and the guidewire together to prevent the needle from damaging or shearing the guidewire.Root cause: based off the provided information and investigation results, the root cause is attributed to operator error as it is believed that the guidewire was damaged while trying to withdraw the guidewire from the introducer needle.

Event Description

Unable to advance guidewire.Operator proceeded by trying to remove the guidewire which they were unable to do.In the effort to remove the guidewire the operator was able to pull approx.44-44.5cms out of the patient, leaving approx.5cms still inside.The operator made a small cutdown to allow for the remaining amount of the guidewire to be removed, this also failed.The patient was then taken to the anaesthetic room (controlled environment as patient on anticoagulants) where a 18g cannula plastic component was fed over guidewire, forward pressure with the cannula and firm pull on wire resulted in guide wire coming free.The 45cm guidewire was remeasured and now measured at 73cm with distal coil very elongate and fine.Uss guided cannulation of right basilic vein.Difficult cannulation as vein very compressible - patient dry.First pass cannulation with flashback from needle.Guidewire advanced.Unable to advance sufficiently so withdrawn.Unable to fully withdraw guidewire from arm.Guidewire gently twisted and pulled - still unable to remove from arm.Measured guidewire - approx.44-44.5cms external.Guidewire is 45cms long therefore 0.5-1cm remained in the pts arm.Examined with ultrasound - unable to definitively see tip of guidewire ?in the vein or stuck to subcutaneous tissue.Small cutdown made - still unable to remove guidewire.Guidewire secured with numerous pieces of steristrip, haemostasis achieved and dressing applied to exit site.Patient taken to anaesthetic room (controlled environment as patient on anticoagulants) by consultant anaesthetist who had taken advice from consultant vascular surgeon.18g cannula plastic component only fed over guidewire, forward pressure with cannula and firm pull on wire resulted in wire coming free.Wire initially 45cm now very stretched 73cm with distal coil very elongate and fine.Uss at end of procedure no obvious wire remaining in vein.

• Brand Name: PRIMEMIDLINE
• Type of Device: MIDLINE CATHETER
• Manufacturer (Section D): PFM MEDICAL, INC.; 1916 palomar oaks; suite 150; carlsbad CA 92008
• Manufacturer (Section G): PFM MEDICAL, INC.; 1916 palomar oaks; suite 150; carlsbad CA 92008
• Manufacturer Contact: troy taylor ; 1916 palomar oaks; suite 150; carlsbad, CA 92008 ; 7607588749
• MDR Report Key: 16933655
• MDR Text Key: 315653085
• Report Number: 3013666218-2023-00002
• Device Sequence Number: 1
• Product Code: PND
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K173114
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2023
• Device Model Number: PFM4SML20P (SIMILAR TO PFM4SML20)
• Device Catalogue Number: PFM4SML20P
• Device Lot Number: 2007-040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2023
• Date Manufacturer Received: 04/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/23/2020
• 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