MAUDE Adverse Event Report: EPIMED INTERNATIONAL INC. E-KATH; CATHETER

Model Number A-EP-059

Device Problems Mechanical Problem (1384); Retraction Problem (1536); Human Factors Issue (2948); Device Handling Problem (3265)

Patient Problem No Information (3190)

Event Date 04/12/2017

Event Type  malfunction  

Manufacturer Narrative

On (b)(6) 2017, (b)(6), anesthesiologist at (b)(6), called epimed's qa analyst to report the incident with the e-kath catheter.(b)(6) stated that during the procedure, resistance was felt during catheter insertion.The catheter was also veering off midline once through the needle.Upon removal of the catheter, the account noticed the proximal tip was missing, but the internal spring was intact because the device was not returned to epimed, a formal investigation could not be conducted.However, the account stated that they were using epimed's flexible introducer cannula (fic) in conjunction with the e-kath catheter and that they were experiencing difficulty when the catheter was inserted through the needle.Epimed warns against doing this in the ifu for the flexible introducer cannula (pi-007, rev.2), under suggested instructions for use steps 4-6; "with desired technique, place the introducer and needle.Apply force to the hub of the needle when inserting the introducer and needle.Test to confirm proper placement using desired technique.Remove stylet and needle.The flexible introducer cannula is radiopaque and can be verified by fluoroscopy.Pass desired approved device through the flexible introducer cannula." the reporting account did not remove both the stylet and needle prior to inserting the catheter.The i.D.Of the fic's cannula is.065 ±.001" according to (b)(4) (molded flexible cannula introducer).The i.D.Of the 17g tuohy needle is.0475 ±.01" according to (b)(4) (needle, epidural tuohy 17g tw).The o.D.Of the e-kath catheter is.042 ±.002" according to (b)(4) (e-kath).Resistance is expected if trying to insert the catheter through the needle, as the tolerance between the two devices is only.0033" on average, whereas the tolerance between the catheter and the fic cannula is.023".On april 15, 2017, the reporting account stated they would not be returning the devices to epimed for examination, due to their policy restrictions.The account did state that they could arrange an on-site inspection of the device.However, based on description of the event, epimed has concluded that the device failed due to the account not properly following the ifu, and therefore, an inspection of the device is not necessary at this time.Epimed's qa analyst reviewed the batch history records for both the catheter and the fic, revealing no abnormalities within either of the product lots.Epimed has filed an mdr (1316297-2017-0004) for this complaint.To ensure patient safety, epimed will follow up with the account for three-consecutive months.An update summary will be filed in this complaint file after the 3-month follow up is complete.On april 13, 2017, epimed's qa analyst informed the account of the findings and as a precaution, emailed the account a copy of epimed's ifu pi-007.User facility kept device.

Event Description

"prior to infusion, approach was made with the catheter.The catheter was advanced into the sacral hiatus with the needle - once the catheter was through the needle it began veering off midline.Some slight resistance was felt.Contrast was then injected without issue.Once the steroid was injected the user felt slight pressure build-up.The user stopped the procedure and removed the needle and catheter as a unit.Upon removal, the account noticed the proximal tip was missing, but the internal spring was intact.Necessary arrangements are being made for patient to determine the next steps.".

• Brand Name: E-KATH
• Type of Device: CATHETER
• Manufacturer (Section D): EPIMED INTERNATIONAL INC.; 141 sal landrio drive; johnstown NY 12095
• Manufacturer (Section G): EPIMED INTERNATIONAL INC.; 141 sal landrio drive; johnstown NY 12095
• Manufacturer Contact: kris knapp ; 141 sal landrio drive; johnstown, NY 12095
• MDR Report Key: 6562680
• MDR Text Key: 75004603
• Report Number: 1316297-2017-00004
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K954584
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 05/12/2017

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: Physician
• Device Expiration Date: 05/01/2021
• Device Model Number: A-EP-059
• Device Catalogue Number: 154-1912
• Device Lot Number: 11127534
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/12/2017
• Initial Date FDA Received: 05/12/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/26/2016
• 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 Weight: 96