FDA Adverse Event Malfunction Summary report: N

RX LOCKING DEVICE AND BIOPSY CAP

MDR report key: 20189310 · Received September 11, 2024

Report

Report Number
20189310
Event Type
Malfunction
Date Received
September 11, 2024
Date of Event
August 23, 2024
Report Date
September 4, 2024
Manufacturer
BOSTON SCIENTIFIC CORPORATION
Product Code
ODC
Product Problem
Yes
Report Source
User Facility report
Reporter Location
PA
Reporter Occupation
OTHER HEALTH CARE PROFESSIONAL
Health Professional
Yes

Narratives

Description of Event or Problem · 0

RECENTLY, WE WERE UNABLE TO PASS THINGS DOWN OUR ERCP SCOPE DURING A PROCEDURE. AT THE START OF THE PROCEDURE, ALL WAS WELL BUT MID-WAY, WE WERE UNABLE TO PASS ANYTHING DOWN THE CHANNEL. WITH USE OF THE SPD BORESCOPE AND AFTER SOAKING AND HOURS OF ¿NUDGING IT ALONG¿, WE DISCOVERED THE SMALL ROUND SPONGE IN THE BIOPSY CAP POPPED OUT AND INTO THE SCOPE. WE CONTACTED THE REP WHO STATED THAT SEVERAL CAMPUSES HAVE EXPERIENCED THIS BUT DID NOT MENTION WHO THEY WERE IN PARTICULAR. IT SOUNDED LIKE A ¿KNOWN PROBLEM¿ BOSTON SCIENTIFIC HEARS ABOUT. DURING ERCP, UNABLE TO INSTILL CONTRAST OMNIPAQUE VIA DREAMTONE. UPON FURTHER ASSESSMENT, UNABLE TO PASS ANY ADDITIONAL INSTRUMENTS VIA ERCP BUTTON ON WORKING CHANNEL OF SCOPE. ERCP SCOPE SWITCHED OUT AND NEW ERCP SCOPE BROUGHT IN AND USED SUCCESSFULLY WITHOUT MUCH DELAY. ESTIMATED DELAY TIME (INCLUDING TROUBLESHOOTING TIME) OF 15 MINUTES. POST CASE, UPON REPROCESSING OF SCOPE, ENDO TECH NOTED "SPONGE" CONCLUDED TO BE PART OF "ERCP BUTTON" WAS FOUND LODGED WITHIN SAME WORKING CHANNEL. MY LEAD TECH AND I THEN TESTED THE BIOPSY CAP AND EASILY WITH THE PASSING OF A BIOPSY DEVICE, THE SPONGE POPPED OUT. NO FORCE WAS PLACED JUST NORMAL PASSAGE. WE FEEL IT IS A HIGH ENOUGH RISK THAT WE WILL BE REMOVING THE SPONGE IN OUR ERCP PROCEDURES MOVING FORWARD.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
556549 RX LOCKING DEVICE AND BIOPSY CAP ENDOSCOPE CHANNEL ACCESSORY ODC BOSTON SCIENTIFIC CORPORATION M00545260 33786468

Patients

Seq Age Sex Outcome Treatment
1 2 MO Female