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

Model Number 001021X

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 07/27/2022

Event Type  Injury  

Event Description

Summary: bleed in abdomen after using the puma-g system to complete a percutaneous ultrasound gastrostomy (pug) procedure, requiring blood transfusion.The patient was initially experiencing respiratory failure with edema of the airway.After a tracheostomy, they presented with persistent airway edema and suspected superior vena cava (svc) syndrome.The patient was admitted to the or for a bronchoscopy to replace and adjust their existing tracheal tube.Due to persistent airway edema, the patient failed the swallow evaluation and, therefore, was also indicated for a gastrostomy.A pug was completed without complication, involving a single needle stick.The pug site was noted to have some oozing, but bleeding was not significant.Four hours post-pug, the patient was tachycardic with a drop in blood pressure and hemoglobin.Hemoglobin was noted to be 9 approximately 8hrs pre-procedure, 8 immediately post-pug, and 5.9 approximately 8hrs post-pug.A ct scan of the abdomen showed fluid consistent with hematoma with no extravasation of contrast near the greater curvature of the stomach.Gastrostomy tube was noted to be appropriately placed within the greater curvature of the stomach.The patient received a transfusion of 2 units of blood.The bleeding was noted to have self-resolved and approximately 36hrs post-procedure hemoglobin returned to pre-operative level of 9.2.The patient has had no further complications from the procedure.There were no apparent clinical concerns or device malfunctions from the use of the puma-g system.

• Brand Name: PUMA-G SYSTEM
• Type of Device: FEEDING TUBE PLACEMENT AID
• Manufacturer (Section D): COAPTECH; 101 west dickman st; suite 700; baltimore 21230
• Manufacturer (Section G): COAPTECH INC.; 101 w dickman st; baltimore MD 21230
• Manufacturer Contact: 101 w dickman st; suite 700; baltimore, MD 21230 ; 4435746934
• MDR Report Key: 15939704
• MDR Text Key: 305059144
• Report Number: 3015177732-2022-00003
• Device Sequence Number: 1
• Product Code: KGC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183057
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2023
• Device Model Number: 001021X
• Device Lot Number: 2022042002 OR 2022051201
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/12/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: GASTROSTOMY TUBE
• Patient Outcome(s): Required Intervention