MAUDE Adverse Event Report: EPIMED INTERNATIONAL INC. SPIROL; CATHETER

Model Number A-EP-098

Device Problems Device Issue (2379); Device Damaged by Another Device (2915); Device Handling Problem (3265)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Upon return, the spirol catheter was decontaminated per (b)(4) (handling biologically contaminated product).Next, the returned catheter was examined.The catheter's distal tip coating and internal spring were sheared off from the device.Measurement testing was conducted and it was determined that approximately 1 ½" of the catheter's distal end coating and internal spring were sheared off from the device.The sheared portion of internal spring was returned to epimed separated from the returned catheter.This portion of the internal spring was stretched and tangled upon return.Next, the returned catheter was examined using the (b)(4) (ram optical measurement system).During this examination, it was discovered that the direction of the coating shear was from the proximal end of the catheter tracking towards the catheter's distal end.Due to the damage starting approximately 1 ½" from the catheter's distal end and tracking towards the catheter's distal tip, epimed suspects that the damage most likely derived from the catheter being withdrawn while the needle was still in place.This is highlighted in epimed's ifu pi-004 rev.3 (spring guide epidural catheter products) § "warnings: 2.Do not remove catheter while needle is in place.Spring guide catheter and epidural needle must be removed together as a unit to prevent potential catheter damage." within the complaint description provided to epimed, the account reported that during the procedure, the catheter became kinked and was subsequently pulled back out.On (b)(4) 2018, epimed emailed halyard requesting additional information regarding the reported complaint.The information requested was in regards to whether or not the physician drew back on the catheter while the needle was still in place during catheter removal.In addition, epimed requested information on the whereabouts of the sheared portion of catheter coating.However, halyard health reported to epimed that they were unable to obtain this additional information from the reporting account.Although the damage to the catheter could have derived from the catheter being withdrawn while the needle was still in place, it is also possible that the catheter came into contact with an internal structure during manipulation of the catheter while the procedure was being conducted, subsequently causing it to shear.The account reported that an echolong echogenic tuohy needle was used during the reported procedure.This needle is manufactured by halyard health.The needle was not returned to epimed for investigation.The batch history records for the catheter lot in question were reviewed; revealing no abnormalities within the catheter lot.The lot passed all applicable inspections and testing.Due to the nature of the reported complaint, epimed has filed an mdr (1316297-2018-00001) with the fda documenting this incident.Epimed will follow up halyard health for a period of three consecutive months in order to monitor patient health status.Based on the available evidence, epimed suspects that either the catheter was withdrawn by the end-user while the needle was still in place or that the catheter became damaged by an internal structure during manipulation of the catheter while the procedure was being conducted.Halyard health is one of epimed's oem accounts.Therefore, the spirol catheter is supplied to halyard health in an unsterile bulk form and then distributed by (b)(4).

Event Description

While placing a catheter from a t-bloc tray (with epimed catheter) for a nerve block for a total knee surgery the catheter broke.While the catheter was being threaded through, the catheter got kinked.Therefore, the catheter was pulled back out.However, when the catheter was pulled back out, the tip of the catheter was sheared.

• Brand Name: SPIROL
• 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: 7452450
• MDR Text Key: 107085522
• Report Number: 1316297-2010-00001
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K981329
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 04/23/2018

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 Model Number: A-EP-098
• Device Catalogue Number: N/A
• Device Lot Number: 053017SC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/26/2018
• Initial Date FDA Received: 04/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/06/2017
• 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