MAUDE Adverse Event Report: AVANOS MEDICAL INC. UNKNOWN, CATHETERS

Model Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypovolemic Shock (1917); Unspecified Kidney or Urinary Problem (4503)

Event Type  Injury  

Event Description

Avanos medical inc.Received a single report that referenced two different incidences, which were associated with separate units, involving two different patients.This is the second of two reports.Refer to 2026095-2023-00013 for the first report.It was reported, a patient with advanced osteoarthritis of the left knee underwent computer-assisted primary total knee arthroplasty (tka).The patient was diagnosed with a case of traumatic pseudoaneurysm of the superficial femoral artery following the tka, in the setting of an intra-articular on­ q (avanos medical) pain catheter, placed into the knee joint and the adductor canal for postoperative pain control.On po day 8, the patient presented to the emergency (er), reporting swelling, ecchymosis and worsening left knee pain (for the past 3 days).The patient was admitted to the intensive care unit for treatment of hypovolemic shock and acute kidney injury.Computed tomography angiogram was obtained and demonstrated a 5-cm saccular aneurysm of the posterior/medial aspect of the femoral/popliteal artery approximately 12 cm above the level of the knee, with a 4-mm neck; the patient was transferred to the floor on hospital day 2 after resolution of the acute kidney injury.On hospital day 3, the patient was taken by vascular surgery to the catheterization laboratory, where a left lower-extremity angiogram was performed.The sfa was stented; the patient was discharged home the following day.Two (2) weeks postoperatively, there was no evidence of recurrent bleeding and marked improvement in pain and function.

Manufacturer Narrative

The actual complaint product was not returned for evaluation.A review of the device history record is not possible as no lot number was provided.Root cause could not be determined.All information reasonably known as of 17 feb 2023 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by avanos medical inc.Represents all of the known information at this time.Avanos medical inc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the avanos medical complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an avanos medical inc.Product is defective or caused serious injury.

• Brand Name: UNKNOWN, CATHETERS
• Type of Device: CATHETERS
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• Manufacturer (Section G): AVENT S. DE R.L. DE C.V.; ave noruega edificio d-1b; fraccionamiento rubio; tijuana b.c. 22116 ; MX 22116
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 16414993
• MDR Text Key: 309953892
• Report Number: 2026095-2023-00014
• Device Sequence Number: 1
• Product Code: BSY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: NOREPRINEPHRINE, SALINE, VANCOMYCIN; PIPERACILLIN/TAZOBACTAM; TRANSFUSION OF 2 UNITS OF PACKED RED BLOOD CELLS.
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention; Other
• Patient Age: 60 YR
• Patient Sex: Male