VIEWFLEX¿ CATHETER INTERFACE MODULE VIEWMATE¿ ZS3
Received Mar 31, 2023 · Event occurred Mar 23, 2023
Report 2184149-2023-00075 · MDR key 16658423
Device
Generic name
System, Signal Isolation
Manufacturer
St. Jude Medical, Inc.Model number
H701374Catalog number
H701374
Lot number
8862870
Product problems
- Communication or Transmission Problem
- Communication or Transmission Problem
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: B5, D9, G3, H2, H3. ONE VIEWMATE¿ Z CATHETER INTERFACE MODULE WAS RECEIVED FOR ANALYSIS. THE VIEWMATE CIM MADE A RATTLING NOISE WHEN ROTATED. WHEN THE CIM WAS OPENED, BOTH OF THE INTERNAL COILS ARE LOOSE FROM THE CIRCUIT BOARD MOUNTING PROVISIONS. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED. NO NON-CONFORMANCES ASSOCIATED WITH THE REPORTED EVENT WERE IDENTIFIED. BASED ON THE INFORMATION PROVIDED TO ABBOTT AND THE INVESTIGATION PERFORMED, THE REPORTED COMMUNICATION ISSUE WAS ISOLATED TO BOTH BROKEN STRAIN RELIEF (PLASTIC ZIP TIE) ON THE CHOKE COILS.
Description of Event or Problem
THE DELAY IS NOT A REPORTABLE EVENT. AS THIS OCCURRED DURING A LEFT ATRIAL APPENDAGE CLOSURE PROCEDURE.
Description of Event or Problem
DURING THE PROCEDURE, THE CIM DID NOT RECOGNIZE THE TRANSDUCERS. THE CATHETER WAS RESEATED, REPLACED TWICE, THE UNIT WAS POWER CYCLED, AND THE CIM WAS RESEATED WHICH DID NOT RESOLVE THE ISSUE. A SEPARATE ULTRASOUND WAS BROUGHT INTO COMPLETE CASE WITH NO PATIENT CONSEQUENCES.