FDA Adverse Event Malfunction Summary report: N

PUMA-G SYSTEM

MDR report key: 22310254 · Received June 23, 2025

Report

Report Number
3015177732-2025-00002
Event Type
Malfunction
Date Received
June 23, 2025
Date of Event
May 16, 2025
Report Date
June 23, 2025
Manufacturer
COAPTECH, INC.
Product Code
KGC
PMA / PMN Number
K223916
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
FL, US
Reporter Occupation
PHYSICIAN
Health Professional
Yes

Narratives

Description of Event or Problem · 0

DURING THE PUG PROCEDURE, THE USER ADVANCED THE PGW (PIGTAIL GUIDEWIRE) AND IBC (INTERNAL BALLOON CATHETER) AFTER COUPLING UNTIL EXITING FROM THE MOUTH. AFTER CUTTING THE PGW, THE PROCEDURALIST WAS UNABLE TO ADVANCE THE GUIDEWIRE ANY FURTHER DUE TO RESISTANCE. SIMILARLY, RESISTANCE WAS FELT WHEN ATTEMPTING TO REDUCE THE GUIDEWIRE AT THE ABDOMINAL END. A KUB WAS COMPLETED, WHICH SHOWED THAT THE GUIDEWIRE APPEARED TO BE TANGLED OR CAUGHT WITHIN THE ABDOMEN OF THE PATIENT. AFTER ADDITIONAL ATTEMPTS TO TROUBLESHOOT AND 2 HOURS OF ROLLING/MANIPULATING THE GUIDEWIRE FROM BOTH ENDS, THE GUIDEWIRE WAS ABLE TO BE REMOVED FROM THE PATIENT WITHOUT ADDITIONAL INTERVENTION. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. THE PATIENT RECEIVED A SUCCESSFUL PEG THE NEXT DAY, NO COMPLICATIONS REPORTED. NOTE: ALTHOUGH THIS CASE DID NOT REQUIRE MEDICAL OR SURGICAL INTERVENTION TO PREVENT LIFE-THREATENING ILLNESS OR INJURY OR PERMANENT/IRREVERSIBLE IMPAIRMENT TO A BODY STRUCTURE OR A BODY FUNCTION, IF THE TEAM HAD NOT DECIDED TO CONTINUE TO TRY TO DETANGLE THE GUIDEWIRE, OTHER INTERVENTIONS MAY HAVE BEEN PURSUED, LIKE ENDOSCOPY, AS MENTIONED IN THE CUSTOMER'S COMMUNICATION. IN COMPLAINTS OF SIMILAR GUIDEWIRE TANGLING EVENTS, INTERVENTIONS SUCH AS ENDOSCOPY OR LAPAROSCOPY HAVE BEEN UTILIZED TO IMAGE OR REMOVE THE GUIDEWIRE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
838218 PUMA-G SYSTEM FEEDING TUBE PLACEMENT AID KGC COAPTECH, INC. 00100046

Patients

Seq Age Sex Outcome Treatment
1 NA Unknown