inforMED
MalfunctionLDF

TRANSLUMINAL BIPOLAR PACING PROBE

Received Jun 26, 2025

Report 2015691-2025-05218 · MDR key 22341479

Device

Generic name

Electrode, Pacemaker, Temporary

Model number

PE075F5

Lot number

NI

Product problems

  • Detachment of Device or Device Component
  • Detachment of Device or Device Component

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

THE DEVICE EVALUATION IS ANTICIPATED. HOWEVER, THE COMPLAINT CANNOT BE CONFIRMED WITHOUT THE COMPLETION OF A PRODUCT EVALUATION. A SUPPLEMENTAL REPORT WILL BE FORTHCOMING WHEN THE INVESTIGATION IS COMPLETED. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE REVIEWED AGAINST TRENDING CONTROL LIMITS ON A MONTHLY BASIS AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS A PART OF THE MONTHLY REVIEW.

Description of Event or Problem

IT WAS REPORTED THAT DURING USE, THE SWAN-GANZ PACING CATHETER SEPARATED. THE SEPARATED BODY WAS RETRIEVED USING A SNARE AND NO ADDITIONAL TREATMENT WAS REQUIRED. IT IS NOT KNOWN HOW THE CATHETER GOT SEPARATED. IT IS NOT KNOWN WHERE THE CATHETER BODY SEPARATED. THERE WAS NO ALLEGATION OF PATIENT INJURY.

Additional Manufacturer Narrative

ONE BIPOLAR PACING CATHETER WAS RETURNED FOR EVALUATION. THE CUSTOMER REPORT OF CATHETER TIP DETACHMENT ISSUE WAS CONFIRMED. AS RECEIVED, CATHETER TIP WAS COMPLETELY DETACHED FROM BOND JOINT BETWEEN PROXIMAL ELECTRODE AND CATHETER BODY. BOTH LEADWIRES WERE COMPLETELY BROKEN. INDICATIONS OF BONDING MATERIAL WERE VISIBLE ON CATHETER BODY. BALLOON LATEX AND WINDINGS WERE INTACT. NO OTHER VISIBLE DAMAGE WAS OBSERVED FROM THE UNIT. AN ENGINEERING EVALUATION WAS INITIATED TO ASSESS FOR ANY MANUFACTURING RELATED PROCESSES WHICH COULD BE CORRELATED TO THE COMPLAINT. BASED ON THE AVAILABLE INFORMATION THERE IS NO EVIDENCE THAT SUPPORTS OR CONFIRMS THE FAILURE MODE IS ASSOCIATED TO A MANUFACTURING/DESIGN DEFECT, AND A ROOT CAUSE COULD NOT BE ESTABLISHED. AS PART OF THE MANUFACTURING PROCESS, 100% OF THE UNITS GO THROUGH A TIP INSPECTION PROCESS. THE LOT NUMBER WAS NOT PROVIDED THUS A DEVICE HISTORY RECORD WAS NOT REVIEWED. THE INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING PRECAUTION: IT IS POSSIBLE TO STRETCH THE BODY OF THE CATHETER AND CAUSE THE INTERNAL THERMISTOR WIRES TO DETACH, THERE BY BREAKING THE CIRCUIT. BE CERTAIN THAT THE TECHNIQUES OF TESTING AND CLEANING DO NOT INCLUDE A PROCEDURE THAT WOULD STRETCH THE CATHETER, I.E., FORCEFUL WIPING OR STRETCHING OF THE CATHETER.