MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC PULMONARY.BALLOON DILATION CATHETER.PULMONARY.; BRONCHOSCOPE ACCESSORY

Catalog Number	P15L55
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	10/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reports that while dilating a stricture located in the patient's left main bronchus for possible stent placement in an older female patient, a blood vessel was perforated and the patient started hemorrhaging profusely.A code was called, and life-saving protocols were initiated without success.The patient expired due to extreme blood loss/hemorrhaging same-day.The balloon dilatations started at 15atms.The highest inflation/atms reached is currently unknown.The physician stated the patient was at high risk due to the stage 4 lung cancer diagnosis.
Additional Manufacturer Narrative
The suspect device is not expected to return 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.Should the device be located and returned, the investigation will be reopened.

• Brand Name: PULMONARY.BALLOON DILATION CATHETER.PULMONARY.
• Common Device Name: BRONCHOSCOPE ACCESSORY
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC; 1600 merit parkway; south jordan UT 84084
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS INC; 1600 merit parkway; south jordan UT 84084
• Manufacturer Contact: bryson heaton rn ; 1600 merit parkway; south jordan, UT 84084 ; 8012531600
• MDR Report Key: 20404249
• Report Number: 1721504-2024-00077
• Device Sequence Number: 19706331
• Product Code: KTI
• UDI-Device Identifier: 00884450198056
• UDI-Public: 884450198056
• Combination Product (Y/N): N
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/01/2024

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: P15L55
• 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: 10/01/2024
• Initial Report FDA Received Date: 10/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Required Intervention
• Patient Sex: Female