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

Model Number ELL18050TGC

Device Problems Coiled (1098); Cut In Material (2454); Torn Material (3024)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/22/2013

Event Type  malfunction  

Event Description

Drug/diluent: na.Fill volume: na.Flow rate: na.Procedure: left shoulder decompression.Cathplace: interscalene block.Date of surgery: (b)(6) 2013.It was reported that a life tech catheter was sheared.The pt removed the catheter by himself on (b)(6) 2013 and did not mention the catheter was broken until (b)(6) 2013.The pt would be going to the hospital today for an evaluation.The patient's current condition was reported to be fair.It was estimated a 5 to 7 centimeter catheter segment was retained inside the pt.The retained segment has not been removed at this time.The pt would undergo mri to locate the portion of catheter that was indwelling.The pt did not experience discomfort during catheter removal, but reported it was slightly difficult to pull.The resistance met was reported to be 1 out of a scale of 0-5.The catheter segment that came out appeared to have a clean cut at an angle.The sales rep called and reported that he was able to talk to the pt and the anesthesiologist.The surgery and the interscalene block had been uneventful.The pt had great pain relief during infusion.Pt has an x-ray earlier today, but the catheter could not be visualized.The pt would be undergoing an mri in the afternoon for an attempt to visualize the catheter.No decision has been made regarding further intervention.At this point, only partial catheter (the removed segment) could be returned.The lot number was not available.Pt underwent an mri to locate the indwelling catheter segment yesterday.It was not visible.The anesthesiologist later performed an ultrasound and thought he saw it under the ultrasound.The pt was referred to an ent specialist for further diagnostic and treatment.At this time, the catheter has not been removed from the pt.Note: the lot number provided is based off the customers purchasing data.

Manufacturer Narrative

Method: a portion of the actual catheter was received for an evaluation and investigation.A visual inspection was performed and photographic images were provided.Per the lot number obtained from the data base a device history review (dhr) is in progress.At this time, results are pending completion of the sample evaluation.The sample is undergoing an evaluation that is in progress.Once the investigation and evaluation are completed, a follow-up report will be submitted.Info from this incident will be included in our product complaint and mdr trend reporting system.Add'l investigation may arise from ongoing analysis, trend info, or other analysis as appropriate.

• Brand Name: ECHOLONG ECHOGENIC CONTINUOUS NEEDLE/CATHETER
• Type of Device: CATHETER
• Manufacturer (Section D): I-FLOW, LLC; lake forest CA
• Manufacturer Contact: maria wagner ; 20202 windrow dr.; lake forest, CA 92630 ; 9495973957
• MDR Report Key: 3704477
• MDR Text Key: 15199973
• Report Number: 2026095-2014-00014
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052954
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/26/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2016
• Device Model Number: ELL18050TGC
• Device Catalogue Number: 103922600
• Device Lot Number: 0201201267
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/08/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/26/2013
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2013
• 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 Age: 65 YR
• Patient Weight: 100