JAWZ ENDOMYOCARDIAL BIOPSY FORCEPS
Received Jun 6, 2023 · Event occurred May 16, 2023
Report 17070034 · MDR key 17070034
Device
Generic name
Device, Biopsy, Endomyocardial
Manufacturer
Argon Medical Devices, Inc.Model number
190081Catalog number
190081
Lot number
5457408 AND 5512986
Product problems
- Difficult to Open or Close
- Mechanical Jam
- Physical Resistance/Sticking
Patient
25185 DA · Male
- Arrhythmia
- Tachycardia
- Discomfort
- Unspecified Tissue Injury
- Arrhythmia
- Tachycardia
- Discomfort
- Unspecified Tissue Injury
Narrative
Description of Event or Problem
UNDER ECHO GUIDANCE, THE BIOPTOME GOT STUCK IN PRESUMABLY THE RV (RIGHT VENTRICLE), AND THE PROVIDER WAS UNABLE TO PULL IT BACK WITHOUT SIGNIFICANT RESISTANCE AND COULD NOT OPEN THE JAWS OR MANEUVER IT. THE PATIENT WENT INTO AN SVT (SUPRAVENTRICULAR TACHYCARDIA) AND FELT VERY UNCOMFORTABLE. DUE TO HER ARRHYTHMIA AND DISCOMFORT, THE PROVIDER PULLED THE BIOPTOME WITH SIGNIFICANT TENSION NOTED AT THE TIME AND RETRIEVED A FAIRLY LARGE PIECE OF TISSUE ON THE END THOUGH THE JAWS REMAINED SHUT. SHE COULD NOT RELEASE THE TISSUE PIECE WHICH WAS STILL ATTACHED TO THE BIOPTOME. THE PATIENT IMMEDIATELY FLIPPED OUT OF HER SVT RHYTHM, AND FELT BETTER AND REMAINED HEMODYNAMICALLY STABLE.