MAUDE Adverse Event Report:

Lot Number N/A

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Hemoptysis (1887)

Event Date 12/28/2017

Event Type  Injury  

Manufacturer Narrative

A spiration representative talked with dr.(b)(6) and obtained the following additional information: at least 4-5 valves were placed in the right lower lobe post-lobectomy for persistent air leak; he is unsure why valves were not removed after 6 weeks; there was an attempt to remove them about 6 months ago, but they were unable to, granulation around the valves made them difficult to remove; from a ct scan he could see that the removal rod is probably against an airway wall, he thinks it is against a blood vessel in the airway wall and therefore the episodes of coughing up blood.Patient reported that every time he bends over he coughs, he has significant chest discomfort and he coughs up blood.Otherwise the patient is fine.The patient has not been admitted to the hospital but these symptoms are affecting his quality of life.Spiration¿s medical monitor, dr.(b)(6), also spoke with dr.(b)(6).Dr.(b)(6)confirmed the above information and indicated that dr.(b)(6) plans to schedule a bronchoscopy procedure with the patient within the next few weeks.Dr.(b)(6) believes the diagnostic bronchoscopy and possible valve removal are the appropriate next steps.He reviewed with dr.(b)(6) methods for valve removal and asked dr.(b)(6) for follow-up.Dr.(b)(6) says that it is possible that the hemoptysis is related if the valve is irritating or compromising a blood vessel in the airway.The bronchoscopy should enable visual confirmation whether this is occurring.

Event Description

According to sales manager "physician is managing a patient who apparently had valves placed post lobectomy back in (b)(6) 2016 by another physician dr.(b)(6).Dr.(b)(6) is no longer at this facility.For some reason the valves were never removed.Now the patient is experiencing episodes of coughing up blood.Dr.(b)(6) has not scoped the patient yet, but the patient is expected to return after the holidays for further evaluation.The patient asked that his condition be reported to the manufacturer, so he called me".

• Manufacturer Contact: cyndy adams ; 6675 185th ave ne; redmond, WA 98052 ; 425636-545
• MDR Report Key: 7223118
• MDR Text Key: 98422447
• Report Number: 3004450998-2018-00003
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: N/A
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/28/2017
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1