MAUDE Adverse Event Report: CHESS MEDICAL INC. NAJA; GASTROINTESTINAL TUBE AND ACCESSORIES

Model Number	9A-03110
Medical Device Problem Codes	Use of Device Problem (1670); Deformation Due to Compressive Stress (2889); Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific that a naja gastrointestinal balloon catheter was used during an endoscopic ultrasound guided gastrojejunostomy (eus-gj) on (b)(6) 2026.During removal of naja balloon catheter, the distal balloon would not deflate.The catheter was cut with a wire cutter, and the physician let the air gradually come out.Additionally, there was a kink in the catheter near the hub.The procedure was completed with the original device.No patient complications were reported as a result of the event.
Additional Manufacturer Narrative
Block h6: imdrf code a140101 captures the reportable event of failure to deflate.Imdrf code f2301 captures the reportable event of additional device required.
Additional Manufacturer Narrative
Block h6: imdrf code a140101 captures the reportable event of failure to deflate.Imdrf code f2301 captures the reportable event of additional device required (wire cutter).Correction: correction to field h1: type of reportable event.
Event or Problem Description
It was reported to boston scientific that a naja gastrointestinal balloon catheter was used during an endoscopic ultrasound guided gastrojejunostomy (eus-gj) on (b)(6) 2026.During removal of naja balloon catheter, the distal balloon would not deflate.The catheter was cut with a wire cutter, and the physician let the air gradually come out.Additionally, there was a kink in the catheter near the hub.The procedure was completed with the original device.No patient complications were reported as a result of the event.
Additional Manufacturer Narrative
Block h6: imdrf code a140101 captures the reportable event of failure to deflate imdrf code f2301 captures the reportable event of additional device required (wire cutter).Block h11: investigation results summary.The naja gastrointestinal balloon catheter was not returned for analysis as it was disposed.Therefore, the technical analysis could not be performed.The reported event of balloon failure to deflate could not be confirmed due to the lack of evidence.A review of the device history record (dhr) was performed.The review of the dhr identified that there were no process related non-conformances, scrap, or rework performed during the production that could explain the event.The reviews ensure each device meets specification prior to release for use.There is no indication the device manufacturing process contributed to the reported complaint.A risk review was completed and confirmed that the event of balloon failure to deflate and additional device required were defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of unable to exclude device problem.
Event or Problem Description
It was reported to boston scientific that a naja gastrointestinal balloon catheter was used during an endoscopic ultrasound guided gastrojejunostomy (eus-gj) on (b)(6) 2026.During removal of naja balloon catheter, the distal balloon would not deflate.The catheter was cut with a wire cutter, and the physician let the air gradually come out.Additionally, there was a kink in the catheter near the hub.The procedure was completed with the original device.No patient complications were reported as a result of the event.

• Brand Name: NAJA
• Common Device Name: GASTROINTESTINAL TUBE AND ACCESSORIES
• Manufacturer (Section D): CHESS MEDICAL INC.; 1010 sainte-catherine quest; 3rd floor suite 3-115; montreal H3B 5 L1; CA H3B 5L1
• Manufacturer (Section G): AGILE MV INC; 3700 st patrick st suite 102; montreal, qc H4E 1 A2; CA H4E 1A2
• Manufacturer Contact: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 24316050
• Report Number: 3005099803-2026-00562
• Device Sequence Number: 17555265
• Product Code: FGD
• UDI-Device Identifier: 00191506060985
• UDI-Public: (01)00191506060985(17)260902(10)1602400
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K223890
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/31/2026

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/02/2026
• Device Model Number: 9A-03110
• Device Catalogue Number: 9A-03110
• Device Lot Number: 0001602400
• 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: 01/15/2026
• Supplement Date Received by Manufacturer: 01/15/2026; 03/06/2026
• Initial Report FDA Received Date: 02/11/2026
• Supplement Report FDA Received Date: 02/11/2026; 03/31/2026
• Date Device Manufactured: 08/11/2025
• 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: Required Intervention
• Patient Sex: Unknown