MAUDE Adverse Event Report: EPIMED INTERNATIONAL INC. 20G SPIROL CATHETER

Model Number A-EP-098

Device Problems Difficult to Remove (1528); Positioning Problem (3009)

Patient Problem No Information (3190)

Event Date 04/15/2016

Event Type  malfunction  

Manufacturer Narrative

During epimed's investigation, tensile testing was performed using epimed's ce-021 (tensile tester - tinius olsen).The tensile test was performed on the returned 20g spirol catheter.The tensile test was completed, yielding a result of (b)(4).Based on the information offered by (b)(6) after numerous queries, it remains unknown how or why the end-user tied the catheter in a knot around the patient's nerve.Regardless, it was revealed by (b)(6) sales representative, (b)(6) that the catheter may have been threaded too far into the patient.Upon return to epimed, it was discovered that the catheter in question was severely stretched, which possibly indicates that the end-user experienced resistance (most likely due to the catheter being tied in a knot).Due to this resistance, it was decided by the administering physician to have the catheter removed (through an additional surgery) in the or.During the or surgery, the surgeon was unable to remove the entire catheter and had to cut the distal end of the catheter, leaving approximately a 6cm piece of catheter within the patient.(b)(6) stated on behalf of the account that the patient is doing well and that there have been no adverse events, patient harm, or infection reported regarding the incident.There was no report of injury, harm, or damage to the nerve.Per the (b)(6) sales rep, "the doc told me the patient is doing fine/ok.The patient has no issues and has "been very cool" about what happened.The doctor stated that "as long as the patient doesn't have any issues with what was left in, he said they plan to leave it in." epimed requested additional clarification regarding the statement, "as long as the patient doesn't have any issues".(b)(6) responded stating, "a decision to remove the catheter fragment would be based on any issues the patient would have on the remaining catheter fragment." at this time,(b)(6) has not heard about any issues related to the remaining piece of catheter fragment.Epimed has suggested to (b)(6) that the account consult a neurosurgeon regarding the location of the remaining catheter fragment to aid in the determination of removal.Epimed believes that the catheter became entangled due to improper placement related to the physician's handling technique.Epimed has determined that the catheter in question was in no way at fault.The remaining 6cm catheter fragment was left within the patient due to account cutting the device, not as a result of device failure, i.E.Tensile strength.The tensile test results indicate that the catheter was well above the minimum standard specifications.Regardless, this is the first complaint of its kind for epimed, deeming this an isolated incident.Epimed will continue to monitor future complaints to determine if adverse trending is occurring.(b)(6) has filed and mdr to the u.S.Fda regarding this incident.As an additional measure of safety per decision tree (ihr-025), epimed concluded that it was necessary to also report the incident to the u.S.Fda.However, per epimed's decision tree for determination of vigilance reporting, epimed has concluded that completing a vigilance report is not required by guidance document meddev 2.12-1 rev.8 at this time.The rationale for this decision is because epimed's device (20g spirol catheter) was not suspected of being a contributory cause of the reported complaint, i.E.The device did not cause the incident.

Event Description

On (b)(6) 2016, (b)(6) complaint technician emailed the complaint report below.He stated that he was sending epimed some catheter fragments.He observed the catheter under magnification and the catheter appeared sheared and the other end appeared pulled on the other end.Territory manager, (b)(6) reported that the spirol catheter lot is unknown.During the procedure, the catheter became inadvertently wrapped around and tied in a knot around the patient's nerve.Per (b)(6), the doctor may have threaded the catheter too far.The ct scan showed the catheter tied in a knot around the nerve.The patient had to be transferred to the o.R to have the remaining piece of catheter removed.There is no report of injury or infection as a result of this incident.There was no report of injury, harm, or damage to the nerve.On (b)(6) 2016, (b)(6) received an email from (b)(6) with additional information; the physician was unable to retrieve all of the catheter while the patient was in the operating room.A piece of catheter approximately 6cm in length remains in the patient.To date, there has been no infection or patient harm as a result of this incident.

• Brand Name: 20G SPIROL CATHETER
• Type of Device: 20G SPIROL 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: nate wrabel ; 141 sal landrio drive; johnstown, NY 12095 ; 5187250209
• MDR Report Key: 5766441
• MDR Text Key: 48716926
• Report Number: 1316297-2016-00004
• 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,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/27/2016

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: HALYARD # 70148607
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/07/2016
• Initial Date FDA Received: 07/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Age: 67 YR