FDA Adverse Event Malfunction Summary report: N

ACUMEN LEAD DELIVERY SHEATH

MDR report key: 704019 · Received April 20, 2006

Report

Report Number
3004857433-2006-00001
Event Type
Malfunction
Date Received
April 20, 2006
Date of Event
March 30, 2006
Report Date
April 20, 2006
Manufacturer
ACUMEN MEDICAL, INC.
Product Code
DYB
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
FL, US
Reporter Occupation
PHYSICIAN

Narratives

Description of Event or Problem · 1

THE PHYSICIAN WAS ATTEMPTING TO PLACE A BIVENTRICULAR LEAD IN THE VESSELS DISTAL TO THE CORONARY SINUS (CS). AFTER INTRODUCTION OF A 0.014" GUIDEWIRE INTO THE CS, THE PHYSICIAN ADVANCED THE LDS CATHETER INTO THE PATIENT'S ATRIUM. DUE TO THE PATIENT'S ANATOMY, THE GUIDEWIRE PROLAPSED OUT OF THE CS DURING THE ADVANCEMENT. THE PHYSICIAN BACKED THE GUIDEWIRE INTO THE GUIDEWIRE LUMEN OF THE LDS CATHETER AND INTRODUCED A 5F MARINER CATHETER THROUGH THE DELIVERY LUMEN OF THE LDS CATHETER IN ATTEMPT TO RECOVER THE POSITION OF THE CS. ONCE THE POSITION OF THE CS WAS IDENTIFIED, THE PHYSICIAN CANNULATED THE CS WITH THE MARINER. HE THEN ADVANCED THE LDS SHEATH OVER THE MARINER INTO THE CS. THE PHYSICIAN REMOVED THE MARINER CATHETER AND INTRODUCED AN APPROPRIATE LV LEAD THROUGH DELIVERY LUMEN OF THE LDS CATHETER. THE LEAD WAS PLACED, AND PACING THRESHOLDS WERE CHECKED. THE PHYSICIAN USED A QUICK MOTION TO SIMULTANEOUSLY SLIT AND REMOVE THE LDS CATHETER FROM THE PATIENT. IT WAS UPON REMOVAL THAT IT WAS NOTED THAT THE DISTAL PORTION OF THE DEVICE WAS NOT ATTACAHED TO THE PROXIMAL PORTION OF THE DEVICE. THE PHYSICIAN DETERMINED IT WAS WITHIN THE PATIENT'S BEST INTEREST NOT TO ATTEMPT TO RETRIEVE THE DISTAL PORTION OF THE DEVICE. A CHEST X-RAY WAS PERFORMED, AND IT WAS VERIFIED THAT THE DISTAL PORTION OF THE LDS CATHETER REMAINED ENVELOPED AROUND THE LV LEAD WITHIN THE RIGHT ATRIUM AND WAS THEREFORE EFFECTIVELY INCARCERATED BY THE LV LEAD. THE PATIENT DID NOT EXPERIENCE ANY ACUTE ADVERSE EVENTS. THE PHYSICIAN FELT THIS PATIENT WITH ADVANCED HEART FAILURE AND A NEWLY IMPLANTED CRT-D DEVICE WILL LIKELY NOT EXPERIENCE SIGNIFICANT SEQUELAE OVER HIS LIFESPAN SECONDARY TO PRESENCE OF THE INCARCERATED DISTAL PORTION OF THE LDS CATHETER. AT A ROUTINE ONE-WEEK POST-PROCEDURE FOLLOW-UP VISIT, THE PATIENT HAD NOT EXPERIENCED ANY ADVERSE EVENTS.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 ACUMEN LEAD DELIVERY SHEATH INTRODUCER, CATHETER DYB ACUMEN MEDICAL, INC. LDS-10-65 H05-0144

Patients

Seq Age Sex Outcome Treatment
1 74 YR