MAUDE Adverse Event Report: LIGHTED STYLET TO AID; STYLET, TRACHEAL TUBE

Device Problems Break (1069); Device Fell (4014)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/20/2022

Event Type  Injury  

Event Description

Distal portion of lta stylet broken and lost in trachea, required bronchoscopy for removal.Lta administered under glideslope visualization prior to placement of ett.With admin of lidocaine distal portion of lta stylet noted to be broken/between vc.Attempt made at manual removal but broken piece advanced past vc and into trachea.Decision made to secure airway and proceed with bronch to retrieve foreign body.Pt intubated with glide 3, 6.0nim placed without difficulty.No desaturation or ventilation issue.Bronch by surgeon confirmed broken stylet in r mainstem bronchus.6.0nim ett exchanged for 8.0ett using glide 3 to facilitate removal of foreign body with bronch.No desaturations or ventilation issues throughout.Bronch by surgeon with successful retrieval of broken stylet.Once removed broken piece, examined and it fit easily with remaining portion of lta, compared to unbroken lta still within packaging and noted to be same length - confident that no remaining foreign body remaining within airway.Ett then exchanged back to 6.0nim ett for procedure.As patient experienced no immediate complications relating to foreign body, decision to proceed with planned procedure.Fda safety report id# (b)(4).

• Brand Name: LIGHTED STYLET TO AID
• Type of Device: STYLET, TRACHEAL TUBE
• MDR Report Key: 14934938
• MDR Text Key: 295449217
• Report Number: MW5110695
• Device Sequence Number: 1
• Product Code: BSR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 06/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 67 KG