MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP XPRESS LOPROFILE ENT 6X20MM, FINAL PACKA; BALLOON DILATION CATHETER SYSTEMS

Catalog Number	LPLF-106-I
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bradycardia (1751); Asystole (4442)
Date of Event	12/08/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a bilateral balloon dilation of the eustachian tubes using the xpress balloon, the patient had trigeminocardiac reflex.At inflation of the balloon on each side, the patient went into asystole for 5 seconds before returning to bradycardia and then returning to normal post balloon dilation.The treatment was completed successfully with no delays, and no additional medical intervention was required.Additional information is currently being requested.
Event or Problem Description
The surgeon provided additional information that no anatomical abnormalities noted in the patient ct scan prior to procedure.No medications were provided.The patient is noted to be doing well in post procedure consultation.
Additional Manufacturer Narrative
Follow up report submitted to document additional information in b5.

• Brand Name: XPRESS LOPROFILE ENT 6X20MM, FINAL PACKA
• Common Device Name: BALLOON DILATION CATHETER SYSTEMS
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• Manufacturer (Section G): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• Manufacturer Contact: kelsey barla ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 23818406
• Report Number: 3015967359-2025-01723
• Device Sequence Number: 13278656
• Product Code: PNZ
• UDI-Device Identifier: 00857326005017
• UDI-Public: (01)00857326005017(17)270401(10)25112053
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K163509
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2026

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: LPLF-106-I
• Device Lot Number: 25112053
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/08/2025
• Supplement Date Received by Manufacturer: 01/22/2026
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 02/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/22/2025
• 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: Other
• Patient Sex: Unknown