MAUDE Adverse Event Report: TRANSTRACHEAL SYSTEMS, INC. SCOOP; SCOOP TRANSTRACHEAL OXYGEN CATHETER

Model Number C-LF

Device Problems Device Expiration Issue (1216); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Hemorrhage/Bleeding (1888); Swelling (2091); Nasal Obstruction (2466)

Event Date 11/29/2016

Event Type  Other  

Event Description

Our company was notified of an incident that involves the use of our single patient use, disposable transtracheal oxygen catheter.The product did not fail.The daughter of a patient using the catheter called our office and later sent documents via fax supporting her concern.Her mother (patient) requires supplemental oxygen through a transtracheal oxygen catheter as prescribed by her pulmonary physician.A prescription for the products was written correctly with a 90 day replacement cycle.The prescription is in compliance with product labeling and fda 510k listing.The products are distributed through (b)(4) and are (b)(6).On two occasions of nearly a year apart, the daughter pleads in a letter for replacements catheters from the oxygen company because over extended use may be contributing to "a bleeding throat." during the phone conversation with the daughter, routine cleaning protocols were reviewed and if bleeding persisted, immediate medical attention was recommended.It appears the product is over 9 months past due for replacement.She is unable to obtain oxygen through her nasal cannula as the medication keeping her alive for pulmonary hypertension causes her nasal passages to swell and fill with mucus.My mother lies in the hospital at this time with an old catheter that is causing her throat to bleed because of numerous attempts to order new ones with your company.She is on a fixed income and must rely on her oxygen company to supply her the necessary equipment to keep her alive.Our company sent a faxed letter to the home oxygen company requesting replacement catheters within 48 hours.New catheters were received within two days, were put in use and the bleeding subsided.Old product is thought to have been discarded.Follow-up call on 12/19/2016 indicated the patient is doing well and without further bleeding problems.We are confident the home oxygen company will replace catheters as prescribed in the future.Device postmarket surveillance is ongoing.

• Brand Name: SCOOP
• Type of Device: SCOOP TRANSTRACHEAL OXYGEN CATHETER
• Manufacturer (Section D): TRANSTRACHEAL SYSTEMS, INC. ; englewood CO
• MDR Report Key: 6263077
• MDR Text Key: 65468295
• Report Number: MW5067310
• Device Sequence Number: 1
• Product Code: BTO
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: C-LF
• Device Catalogue Number: C-LF
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 72 YR