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

Model Number	001021X
Medical Device Problem Codes	Inadequate or Insufficient Training (1643); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Bowel Perforation (2668)
Date of Event	03/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2024 a coaptech representative was on-site for a percutaneous ultrasound gastrostomy (pug) procedure at nyp cornell medical center that appeared successful.The patient had a known clinical history of abdominal surgeries, further verified by visible abdominal scar tissue, and the pug was performed despite concerns for abnormal upper gi anatomy and the location of the stomach and balloon under the patient's ribs, both of which are warned about in the puma-g system ifu.Resistance was encountered during g-tube insertion, so a dilating catheter and clamp were used to help pull it through at the abdominal site.An x-ray was captured post-procedure that showed no concerns, and no indication of device malfunction or defect nor any procedural issues with the puma-g system were noted.On (b)(6) 2024 coaptech was notified by hospital staff that the patient had experienced stool leakage at the g-tube site and subsequently received a ct of the abdomen which revealed a gastrostomy tube skiving through the colon.The patient was started on antibiotics and was being observed clinically, with the possibility of needing abdominal surgery if no improvement.No further information has been provided.A suspected colon puncture could cause permanent impairment of a body function if not treated by medical or surgical intervention, and therefore, constitutes a serious injury.The patient was placed on antibiotics and was being observed clinically in case there was a need for surgery on the colon.Colon perforation is a known complication of percutaneous gastrostomy if the tract is not properly identified and imaged for interfering anatomy.Of note, the user did not engage in training that is strongly recommended by coaptech prior to using the device, and warnings within the product information were disregarded during the case.
Additional Manufacturer Narrative
The balloon was visualized via ultrasound under the patient's ribs, which means the identified needle tract was positioned at a shallow angle from the ultrasound probe.Confirmatory fluoroscopic imaging of a safe tract for the needle was recommended by coaptech's representatives due to the balloon placement under the patient's ribs but refused by the proceduralist.Note that the product ifu lists abnormal upper gastrointestinal anatomy as a contraindication and directs the user to hold the handheld magnet "below the ribs" when achieving coaptation with the ibc.The guidewire was captured within the balloon following needle aspiration of blue aspirant and then advanced out of the mouth.The g-tube was placed over the guidewire, and resistance was encountered when pulling the g-tube through the skin even when a rocking method was attempted.The resistance was believed to be related to scarring/adhesions due to the patient's prior surgical history.The skin nick was increased, and due to continued resistance, a dilating catheter was placed over the guidewire on the proximal end.The g-tube dilating tip was pulled through using a kelly clamp, during which a part of the dilator tip was pulled off.The clamp was re-attached and the tube pulled through more easily.The g-tube bolster was secured at 4cm.An x-ray was captured post-procedure that showed no concerns.On (b)(6) coaptech was informed that 3 days post-procedure, the patient was experiencing increased pain at the g-tube site.The following day (4 days post-procedure) stool leakage was noted and a ct of the abdomen was obtained, indicating that the colon was punctured via suspected skiving during needle insertion.Antibiotics were started and surgery was consulted to determine next steps for the patient, but coaptech was not informed of any further clinical events.Without additional information, coaptech believes the colon skiving may have occurred if the full needle tract zone was not imaged with ultrasound and then the needle was inserted out of plane, considering the balloon was targeted under the ribs.Coaptech recommends full tract imaging, ultrasound or otherwise, prior to establishing the gastrostomy tract.

• 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 Contact: 101 w dickman st, suite 700; baltimore, MD 21230 ; 4435746934
• MDR Report Key: 19053183
• Report Number: 3015177732-2024-00001
• Device Sequence Number: 7339075
• Product Code: KGC
• UDI-Device Identifier: 00850026037081
• UDI-Public: (01)00850026037081(17)241130(10)2024011601
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/04/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2024
• Device Model Number: 001021X
• Device Lot Number: 2024011601
• 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: 03/06/2024
• Initial Report FDA Received Date: 04/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/06/2023
• 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