MAUDE Adverse Event Report: EPIMED INTERNATIONAL INC. TUN-L-XL; CATHETER

Model Number A-EP-088

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

Patient Problem No Information (3190)

Event Date 01/17/2017

Event Type  Injury  

Manufacturer Narrative

Upon arrival, the catheter fragment was decontaminated per sop-021 (handling biologically contaminated product).After decontamination, the tun-l-xl fragment was examined.During this review, it was determined that the catheter fragment was from the distal end portion of the device.The returned fragment measured approximately 9" in length.Approximately half the length of the device was missing both the fep outer and pet inner coating.This portion of the returned catheter fragment also had a stretched internal spring and an exposed portion of broken internal safety ribbon.The distal end ball weld remained intact.The proximal end of the returned fragment appeared to have been cut and/or pulled apart due to the cut edge being jagged in appearance.Based on the report provided to epimed by the reporting account, it was determined that this returned catheter fragment was the portion of catheter recovered from the patient during surgery.After examination of the returned devices, the returned (b)(4) (epimed initial complaint report - supplemental) was reviewed.Question #2 of the (b)(4) asks, "did the physician draw back on the catheter while the needle was in place?" to which the reporting account replied, "the physician drew back and advanced the catheter several times during the procedure".Based on the responses provided on the (b)(4) by the reporting account, epimed suspects that the damage to the device may have derived from the catheter being withdrawn while the needle was still in place.This is highlighted in epimed's ifu pi-004 rev.(spring guide epidural catheter products)s "warnings: do not remove catheter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." during catheter placement, if repositioning of the catheter is necessary, epimed warns to use extreme caution within ifu pi-004."warnings: during placement, if repositioning of catheter is necessary use extreme caution.If it is necessary to retract (1-5cm) or rotate the catheter, extreme caution should be taken to ensure needle distal tip, indicated by black arrow on hub, is oriented in the same direction as the distal tip of the catheter." the rx needle that was reported to have been used in conjunction with the tun-l-xl catheter during this procedure was not returned to epimed for investigation.The account was unable to provide epimed with a lot number for either the reported tun-l-xl catheter or the needle that was used in the reported complaint.However, epimed's customer service supervisor provided epimed's quality assurance department the tun-l-xl catheter lot that was purchased by the reporting account prior to the reported incident.The batch history records for this potential catheter lot were reviewed, revealing no abnormalities within the lot.The catheter lot passed all applicable inspections and testing.After reviewing the batch history records, inventory levels were checked for the catheter lot in question.However, no catheters from the lot reported remained in stock.Based on all available evidence, epimed suspects that the reported complaint derived from improper physician technique.It is suspected that the repeated advancement and withdrawal of the catheter by the physician while the needle was still in place led to the catheter coating catching on the heel of the needle's bevel/tip, subsequently shearing the catheter coating.Based on the nature of the reported complaint, epimed will follow-up with the account for a period of three consecutive months to ensure there are no complications to the patient stemming from either the original procedure or the surgical intervention to remove the catheter fragment.

Event Description

On (b)(6) 20167, the physician introduced the catheter through the epidural needle from sacral hiatus and conducted the required procedure.However, during the procedure, the catheter fep outer coating and pet inner coating became sheared approximately 5" from the catheter's distal end.On (b)(6) 2017, they physician found the catheter within the patient from the patient's sacral hiatus to l5.The length of the device was estimated to be 4 to 5 inches in length.On (b)(6) 2017, surgery was performed on the patient in order to retrieve the sheared portion of catheter.During this surgery, the physicians made an incision on the sacral hiatus and located the sheared portion of catheter.The physicians pulled the devices internal spring, which caused the spring to become extended.The physicians then pulled on the devices internal safety ribbon, subsequently removing the sheared device in its entirety.As of (b)(6) 2017, the patient is not in pain and has made good progress since the surgery to remove the sheared catheter.On (b)(6) 2017, the incident was reported to epimed.

• Brand Name: TUN-L-XL
• 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: 7046697
• MDR Text Key: 92588112
• Report Number: 1316297-2017-00010
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K954584
• 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: 11/17/2017

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 Model Number: A-EP-088
• Device Catalogue Number: 155-2540
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/24/2017
• Initial Date FDA Received: 11/20/2017
• 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): Other