MAUDE Adverse Event Report: COAPTECH, INC. PUMA-G SYSTEM; FEEDING TUBE PLACEMENT AID

Model Number	0010475
Medical Device Problem Codes	Difficult to Remove (1528); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Note: although this case did not require medical or surgical intervention to prevent life-threatening illness or injury or permanent/irreversible impairment to a body structure or a body function, if case circumstances were different and the guidewire coiling or kinking had been more severe, other interventions may have been pursued to remove the guidewire.In complaints of similar guidewire tangling events, interventions such as endoscopy or laparoscopy have been utilized to image or remove the guidewire.Findings reference a previous investigation for similar complaint(s).
Event or Problem Description
After successfully establishing through-and-through guidewire access during the percutaneous ultrasound gastrostomy (pug) procedure, the users encountered resistance advancing additional guidewire out of the patient's mouth to feed through the g-tube.The clinical team was able to keep advancing until about 40-50 cm of guidewire was out of the mouth and resistance was met again.The guidewire was then pulled from the abdominal end, and resistance was met with about 10 cm out of the mouth.This sequence of advancing the guidewire out of the mouth and then retracting at the abdominal end was completed again with resistance met from both ends.After advancing the guidewire out of the mouth again until the resistance was felt, the g-tube was fed over the guidewire until the tip of the guidewire was just past the knuckle of the g-tube and clamped to hold the g-tube with the guidewire.The guidewire was pulled slowly from the abdominal end, and when the tapered tip of the g-tube was at the abdominal wall, the user palpated to ensure the guidewire was not coiled.Ultrasound was used to attempt to visualize the guidewire, but it was not seen.The g-tube was pulled through the abdominal wall and final g-tube set up was completed.Gastric fluid was visualized, indicating adequate placement of the g-tube.

• Brand Name: PUMA-G SYSTEM
• Common Device Name: FEEDING TUBE PLACEMENT AID
• Manufacturer (Section D): COAPTECH, INC.; 101 w dickman st; suite 700; baltimore MD 21230
• Manufacturer (Section G): COAPTECH, INC.; 101 w dickman st; suite 700; baltimore MD 21230
• Manufacturer Contact: 101 w dickman st; suite 700; baltimore, MD 21230 ; 4435746934
• MDR Report Key: 24701084
• Report Number: 3015177732-2026-00001
• Device Sequence Number: 18751768
• Product Code: KGC
• UDI-Device Identifier: 00850026037319
• UDI-Public: 010085002603731917260531102025060601
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K223916
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/25/2026

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 Expiration Date: 05/31/2026
• Device Model Number: 0010475
• Device Catalogue Number: 0010480
• Device Lot Number: 2025060601
• 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: 03/03/2026
• Initial Report FDA Received Date: 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: TRACHEOSTOMY TUBE
• Patient Age: 45 YR
• Patient Sex: Male