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

Model Number	001021X
Medical Device Problem Codes	Entrapment of Device (1212); Difficult to Remove (1528); Difficult to Advance (2920)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	05/28/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the complaint investigation, the root cause of the complaint was overfeeding of the guidewire which may be coupled with interference with internal anatomy (i.E., the omentum), preventing movement of the guidewire to complete the procedure prior to surgical intervention.
Event or Problem Description
The initial steps of the percutaneous ultrasound gastrostomy (pug) procedure were completed to achieve coupling between the pigtail guidewire (pgw) and internal balloon catheter (ibc).As the coupled ibc-pgw was fed through the orogastric tract, the nasogastric tube (ngt) was removed as the primary proceduralist thought it was potentially interfering with the ibc removal.Once outside of the mouth, the balloon was not coupled with the pgw (i.E., the pigtail was not inside the balloon).A glidescope was used to examine the oral cavity and pharynx but the pgw was not found.The guidewire was removed from the abdominal end, and the clinical team chose to continue with a second kit.After ibc insertion, the balloon was not visualized immediately.A new ngt was inserted for additional insufflation, after which the balloon was visualized again at 3cm tissue depth.Again, the initial steps of the pug procedure were completed without issue, and the coupled ibc-pgw was advanced through the orogastric tract; this time both were retrieved through the mouth.After retrieving about 15cm of the pgw out of the mouth, the proceduralist felt resistance and was unable to continue advancing the guidewire.The glidescope was used to inspect the oral cavity and pharynx but did not visualize anything abnormal.The proceduralist attempted to reduce the pgw by pulling at both the oral and abdominal ends but only felt resistance.He was able to advance the pgw further at the abdomen but could not pull more from the oral end.At this point, coaptech clinical support suggested taking x-rays to help determine the issue.Imaging revealed an excessive amount of looped guidewire in the abdominal cavity.It was recommended that the doctor continue to try to reduce the guidewire from the abdominal side, which was successful in retrieving about 15cm of additional wire.More guidewire was able to be fed out of the mouth as well.Another x-ray showed a decrease of guidewire in the abdominal cavity but some looping remained.An esophagogastroduodenoscopy (egd) was performed by gi at the bedside, concluding that the excess guidewire was extragastric.The patient was then transported to the or to receive laparoscopy by a surgeon.Findings showed the guidewire looped within a small portion of the omentum.The omentum was dissected, freeing the guidewire, which had no visible damage.The g-tube was inserted using the intact guidewire and a push g-tube kit.The g-tube was secured at 4cm.No further complications or clinical effects related to the pug procedure were reported following the case.

• 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: 19627573
• Report Number: 3015177732-2024-00003
• Device Sequence Number: 7119062
• Product Code: KGC
• UDI-Device Identifier: 00850026037043
• UDI-Public: (01)00850026037043(17)241130(10)XXXXXXXXXX
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 06/27/2024

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 Model Number: 001021X
• 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: 05/28/2024
• Initial Report FDA Received Date: 06/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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.; TRACHEOSTOMY TUBE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 36 YR
• Patient Sex: Male