BETA CATH
Received Oct 4, 2004 · Event occurred Sep 29, 2004
Report MW1033343 · MDR key 557475
Device
Generic name
Intravascular Brachytherapy Treatment
Manufacturer
NovosteModel number
3.5 FR, 40 MMCatalog number
*
Lot number
*
Product problems
- Explanted
- Difficult to Insert
- Difficult to Remove
- Retraction Problem
Patient
74 YR
- Therapy/non-surgical treatment, additional
Narrative
Description of Event or Problem
FAILURE TO RETRACT RADIOACTIVE SOURCE TRAIN. PT WAS UNDERGOING INTRAVASCULAR BRACHYTHERAPY OF CORONARY ARTERY FOR PREVENTION OF RESTENOSIS. ARTERY WAS KINKED DISTAL TO TREATMENT SITE. PHYSICIANS NOTED SOME DIFFICULTY IN ADVANCING SOURCE TRAIN INTO TREATMENT SITE. EXTRA FORCE ON SYRINGE PLUNGER WAS REQUIRED TO MOVE SOURCE TRAIN PAST KINK. AT COMPLETION OF THERAPY THE PHYSICIAN ATTEMPTED TO RETRACT SOURCE TRAIN USING NORMAL MFR'S PROCEDURE (INJECT FLUID INTO RETRIEVAL CHANNEL). SOURCE TRAIN WOULD NOT RETRACT. PHYSICIAN REMOVED ENTIRE CATHETER FROM PT MANUALLY. DURING REMOVAL A SECOND ATTEMPT WAS MADE TO RETRACT SOURCE TRAIN USING NORMAL PROCEDURE. SOURCE TRAIN STILL COULD NOT BE RETRACTED. NO ANTICIPATED NEGATIVE IMPACT ON PT.