MAUDE Adverse Event Report: I-FLOW, LLC ECHOLONG CONTINUOUS ECHOGENIC NEEDLE/CATHETER

Model Number ELL18050TGC

Device Problem Cut In Material (2454)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/22/2014

Event Type  Injury  

Event Description

Fill volume: na.Flow rate: na.Procedure: total knee replacement.Cathplace: left groin.Date of surgery: (b)(6) 2014.An anesthesiologist reported that a catheter sheared off during withdrawing, and she believes that 2cm of the distal tip of the catheter was left in the patient.The anesthesiologist felt some resistance during the removal (rated as level 2 in a scale from 0-5) but she still pulled it with her fingers.She also confirmed that the needle was rotated in order to facilitate the removal of the catheter.At this time, the tip of the catheter was determined to be left in the patient until it becomes medically necessary to remove it.An x-ray may be performed on (b)(6) 2014 to determine the position of the catheter segment.

Manufacturer Narrative

Method: the actual device was reported to be available for return.A review of the device history records (dhr) was conducted for the lot number reported.Results: eval and investigation results will be provided once completed.Conclusions: at this time i-flow is pending the return of the device for an eval.The investigation is ongoing, once completed a follow-up report will be submitted.Info from this incident will be included in our product complaint and mdr trend reporting systems.Ongoing analysis of trend info is used to identify the need for add'l investigation.

• Brand Name: ECHOLONG CONTINUOUS ECHOGENIC NEEDLE/CATHETER
• Type of Device: CATHETER
• Manufacturer (Section D): I-FLOW, LLC; irvine CA
• Manufacturer (Section G): I-FLOW CORP.; 20202 windrow dr.; lake forest CA 92630
• Manufacturer Contact: maria wagner ; 43 discovery, ste 100; irvine, CA 92618 ; 9499232324
• MDR Report Key: 3839283
• MDR Text Key: 4413901
• Report Number: 2026095-2014-00066
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111355
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2016
• Device Model Number: ELL18050TGC
• Device Catalogue Number: 103922600
• Device Lot Number: 2N28205X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/23/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/01/2013
• 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): Other
• Patient Age: 71 YR