MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. ELATION¿; BRONCHOSCOPE ACCESSORY

Catalog Number	P12L30
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	08/22/2024
Type of Reportable Event	Death
Event or Problem Description
The account alleges that during a routine tracheobronchial polyurethane stent follow-up appointment for a female cancer patient currently receiving palliative care due to cancer, the physician noted some narrowing and with minor granulated tissue present at the stent site.The stent was placed for a cancer-related stricture approximately two weeks ago without issue.The patient received one treatment of radiation therapy post-stent implant on an unknown date.The interventional pulmonologist recommended removing the existing stent and upsizing it to a larger stent for the patient.During the stent removal procedure, a pulmonary balloon dilatation catheter was used to dilate the inner diameter of the stent under fluoroscopic guidance and an attempt to remove the stent with a pair of raptor forceps was initiated successfully.The actual stent removal process was unremarkable.Soon after the stent was removed bleeding was noted at the stent site.Suction was attempted but unsuccessful in controlling the hemorrhaging.The patient became hemodynamically unstable and a code blue was initiated.Life-saving protocols were attempted for this patient with no success.The patient died in the procedure room.The physician states the balloon and stent system did not malfunction during this procedure, both medical devices operated as intended.
Additional Manufacturer Narrative
The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.A review of the device history and complaint database could not be performed since the lot number was not provided.

• Brand Name: ELATION¿
• Common Device Name: BRONCHOSCOPE ACCESSORY
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan UT 84095
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan UT 84095
• Manufacturer Contact: bryson heaton ; 1600 merit parkway; south jordan, UT 84095 ; 8012084662
• MDR Report Key: 20077133
• Report Number: 1721504-2024-00060
• Device Sequence Number: 6405139
• Product Code: KTI
• UDI-Device Identifier: 00884450398944
• UDI-Public: 00884450398944
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K161392
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/22/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: P12L30
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2024
• Initial Report FDA Received Date: 08/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 68 YR
• Patient Sex: Female