MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-CALIF GATEWAY OTW 2.0MM X 15MM - HDE; CATHETER, BALLOON TYPE

Catalog Number	M0032072215200
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported during the procedure the subject balloon burst before reaching nominal pressure.The balloon was replaced and the procedure was completed successfully with no clinical consequences to the patient.
Additional Manufacturer Narrative
H4 manufacturing date ¿ added d4 expiration date ¿ added d4 gtin # - added based on the results of the device history record (dhr) review, there is no indication that the device, labeling or packaging failed to meet its specifications when released.The visual inspection was not performed due to the device not being returned.The functional inspection was not performed due to the device not being returned.The reported balloon leak during preparation could not be confirmed and it cannot be confirmed that the device met specification, as the device was not returned.The reported event is covered in the device directions for use (dfu).As well, the risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.It was reported that the subject balloon burst before reaching nominal pressure.No further information was available.There are a number of potential causes for the reported event including damage sustained to the device prior to use, damage sustained to the device during use and interaction between the device and other devices.As the device was not returned and a review of all available information fails to indicate an assignable cause for the reported event, an assignable cause of undeterminable will be assigned to this complaint.
Event or Problem Description
It was reported during the procedure the subject balloon burst before reaching nominal pressure.The balloon was replaced and the procedure was completed successfully with no clinical consequences to the patient.

• Brand Name: GATEWAY OTW 2.0MM X 15MM - HDE
• Common Device Name: CATHETER, BALLOON TYPE
• Manufacturer (Section D): STRYKER NEUROVASCULAR-CALIF; 47900 bayside parkway; fremont CA 94538
• Manufacturer (Section G): STRYKER NEUROVASCULAR-CALIF; 47900 bayside parkway; fremont CA 94538
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 22683251
• Report Number: 3008853977-2025-00018
• Device Sequence Number: 13125613
• Product Code: GBA
• UDI-Device Identifier: 08714729791416
• UDI-Public: (01)08714729791416(17)270610(10)34208817
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: H050001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: M0032072215200
• Device Lot Number: 34208817
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/15/2025
• Supplement Date Received by Manufacturer: 10/07/2025
• Initial Report FDA Received Date: 07/31/2025
• Supplement Report FDA Received Date: 10/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/10/2024
• 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
• Patient Sex: Unknown