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

Model Number	001021X
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	03/04/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Insufflation was not performed prior to needle sticks, and there were multiple needle sticks while trying to hit the balloon.Insufflation is recommended in all percutaneous gastrostomy methods for a variety of reasons, but of particular relevance in this case, insufflation aids in avoiding the vascular structures surrounding the stomach, particularly in the posterior regions.Even considering the procedural deviations, there were no apparent clinical concerns from the use of the puma-g system, based on confirmation of correct placement of the g-tube and no evidence of organ injury.
Event or Problem Description
Abdominal hemorrhage in peritoneal cavity found and resolved after using the puma-g system to complete a percutaneous ultrasound gastrostomy (pug) procedure.A chest ct confirmed that the stomach was anatomically within the indications for a percutaneous ultrasound gastrostomy (pug) procedure using the puma-g system.During the pug procedure, the physician visualized the balloon, located somewhat under the ribs, via ultrasound, and unsuccessfully attempted balloon puncture without using insufflation.After losing visualization, the physician removed and replaced the balloon in the stomach, establishing a clear view of the balloon.Approximately 5 or 6 needle sticks were attempted before balloon puncture was confirmed with blue aspirant.The remainder of the procedure proceeded without issue through gastrostomy tube placement.No signs of bleeding were apparent at the time the procedure concluded.Within hours of the procedure, the patient became unstable, initially tachypneic, and then went into shock with a bleeding complication.A ct showed blood around the stomach and the g-tube in an acceptable location.An exploratory laparotomy was performed, revealing 2l of blood in the peritoneum.The g-tube was left in place while the blood and clots were cleaned out.Since then, the patient has had no further complications from the procedure.

• Brand Name: PUMA-G SYSTEM
• Common Device Name: FEEDING TUBE PLACEMENT AID
• Manufacturer (Section D): COAPTECH; 101 w dickman st; suite 900; baltimore MD 21230
• Manufacturer (Section G): COAPTECH; 101 w dickman st; suite 900; baltimore MD 21230
• Manufacturer Contact: 101 w dickman st; suite 900; baltimore, MD 21230 ; 4435746981
• MDR Report Key: 14111735
• Report Number: 3015177732-2022-00001
• Device Sequence Number: 5251341
• Product Code: KGC
• UDI-Device Identifier: 00850026037043
• UDI-Public: 010085002603704317220630102022013101
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/11/2022

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: 06/30/2022
• Device Model Number: 001021X
• Device Lot Number: 2022013101
• 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: 03/11/2022
• Initial Report FDA Received Date: 04/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2022
• 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 Age: 57 YR
• Patient Sex: Female