ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER

Additional Manufacturer Narrative

D2A - COMMON DEVICE NAME: ADDITIONAL NAMES: GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY; LJE CATHETER, NEPHROSTOMY D2B - PROCODE: ADDITIONAL PRODUCT CODES: GBO, LJE E1 - CUSTOMER (PERSON): (B)(6). H3 - DEVICE EVALUATED BY MFG? DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED OR THAT A DEATH OR SERIOUS INJURY OCCURRED; NOR IS IT ADMISSION THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

Description of Event or Problem

IT WAS REPORTED THAT THE HUB OF AN ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER LEAKED DURING USE. AS A RESULT, A NEW DRAINAGE TUBE WAS IMMEDIATELY PLACED. A PHOTO PROVIDED BY THE CUSTOMER SHOWS A CATHETER INDWELLING IN A PATIENT WITH LEAKAGE AT THE MAC-LOC ASSEMBLY. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.