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

Model Number	0010210
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/09/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
During the percutaneous ultrasound gastrostomy (pug) procedure, the proceduralist performed the steps to achieve through-and-through guidewire access (i.E., guidewire is positioned through the orogastric tract exiting at the mouth and abdominal puncture site).The user noted that the abdominal wall thickness was about 5 cm (above the indication of 4.5 cm for the puma-g system) and that patient positioning was challenging during the procedure.The first guidewire cut was considered unsatisfactory (i.E., ends were not clean cuts), so a second cut was performed, which, upon review, the user believes was located outside and distal (away from the pigtail) to the marked section of the guidewire intended for cutting.Of note, the puma-g guidewire is constructed of a core wire and outer spring-coil wire, which, when cut outside of the marked glued section, can cause the spring-coil wire to unravel.The g-tube was inserted through the mouth and fed over the guidewire through the established tract but had not yet existed at the abdominal site when the user noticed that the guidewire had separated.He stopped the procedure and notified a surgeon, who arrived within 30 minutes to remove the spring-coil wire that remained in the patient at the tract site.The g-tube was removed and there were no further complications at this time.

• Brand Name: PUMA-G SYSTEM
• Common Device Name: FEEDING TUBE PLACEMENT AID
• Manufacturer (Section D): COAPTECH, INC.; 101 w dickman st; suite 900; baltimore MD 21230
• Manufacturer (Section G): COAPTECH, INC.; 101 w dickman st; suite 700; baltimore MD 21230
• Manufacturer Contact: michelle garner ; 101 w dickman st; suite 900; baltimore, MD 21230 ; 4435746934
• MDR Report Key: 16595696
• Report Number: 3015177732-2023-00001
• Device Sequence Number: 4551312
• Product Code: KGC
• UDI-Device Identifier: 00850026037043
• UDI-Public: (01)00850026037043(17)231031(10)2023011001
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K183057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/22/2023

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 Expiration Date: 10/31/2023
• Device Model Number: 0010210
• Device Lot Number: 2023011001
• 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: 03/09/2023
• Initial Report FDA Received Date: 03/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2023
• 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: GASTROSTOMY TUBE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown