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

Model Number	001021X
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	04/02/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Although a vessel bleed is not typically a life-threatening injury that results in permanent impairment or damage, this case resulted in significant hemorrhage requiring surgery.The exploratory laparotomy was necessary to prevent further damage from the internal bleeding, as well as to confirm that no other serious injuries existed.Because this event necessitated medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure, coaptech believes it meets the definition of a serious injury.
Event or Problem Description
A pug procedure was performed on (b)(6) 2024 using the puma-g system.The patient's abdomen was described as benign, and the balloon was visualized clearly under ultrasound at about a 4cm tract depth.The balloon was moved left to avoid liver margin visualized on the patient's right side.The primary proceduralist attempted to puncture the balloon with the needle 5 times without success.Another proceduralist then attempted the needle puncture after shifting further left.The sixth puncture aspirated frank blood, after which the case was aborted due to bleeding concerns.Of note, coaptech does not recommend multiple puncture attempts, advising no more than three prior to aborting in product training.The patient received ct contrast that showed a large quantity of blood inside the abdomen and was started on pressors.A blood transfusion was provided and exploratory laparotomy was performed to stop the bleeding, revealing a blood in the abdomen.The operating surgeon commented that the bleeding originated from a small vessel on the omentum.There were no other signs of needle trauma nor errant needle placement.A surgical g-tube was placed during the surgery.The patient was described as recovered at the time of notification.No device malfunction nor organ injury was reported.Bleeding is a known complication that is listed in the product ifu, and the same injury could have occurred with any percutaneous approach to g-tube placement (e.G., peg or prg).

• 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: 19174725
• Report Number: 3015177732-2024-00002
• Device Sequence Number: 7938339
• Product Code: KGC
• UDI-Device Identifier: 00850026037043
• UDI-Public: (01)00850026037043(17)241130(10)2023121201
• 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): 04/23/2024

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: 2023121201
• 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: 04/03/2024
• Initial Report FDA Received Date: 04/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/12/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown