FDA Adverse Event Malfunction Summary report: N

SET ROTAREX S 6F 135CM (STRAUB MEDICAL)

MDR report key: 19433945 · Received May 31, 2024

Report

Report Number
19433945
Event Type
Malfunction
Date Received
May 31, 2024
Date of Event
April 30, 2024
Report Date
May 29, 2024
Manufacturer
STRAUB MEDICAL AG
Product Code
MCW
Product Problem
Yes
Report Source
User Facility report
Reporter Location
OH
Reporter Occupation
RISK MANAGER
Health Professional
N

Narratives

Description of Event or Problem · 0

A 0.035 GLIDEWIRE AND 0.035 TRAILBLAZER CATHETER WERE USED TO TRAVERSE THE LONG LEFT SFA STENTS OCCLUSION. TRUE LUMEN PLACEMENT IN THE POPLITEAL ARTERY WAS CONFIRMED WITH INJECTION OF CONTRAST. THE WIRE WAS EXCHANGED OUT FOR THE ROTA REX WIRE. THE ROTA REX DEVICE WAS THEN USED TO PERFORM MECHANICAL THROMBECTOMY IN THE PROXIMAL SFA STENTS. THE DEVICE HEATED UP AND THERE WAS POOR SALINE FLOW THROUGH THE CATHETER. UPON ATTEMPT TO RETRIEVE THE DEVICE, THE HELIX COIL BECAME SEPARATED AND THE TIP OF THE HELIX IS CAUGHT ON WHAT APPEARS TO BE A STENT STRUT IN THE PROXIMAL SFA. THE REMAINDER OF THE ROTA REX CATHETER WAS REMOVED AND THE HELIX AND TIP REMAINED WITHIN THE SHEATH AND EXTENDING INTO THE PROXIMAL SFA. WIRE ACCESS THROUGH THE HELIX WAS MAINTAINED WITH THE DEVICE WIRE. A 10 MM SNARE WAS ADVANCED OVER THIS WIRE AND USED TO GRASP THE INTRA SHEATH PORTION OF THE HELIX BUT THE TIP OF THE HELIX COULD NOT BE REMOVED FROM THE PROXIMAL SFA STENT. A LARGER TRIPLE SNARE SHEATH WAS ADVANCED OVER THE WIRE AND OVER THE HELIX BUT WHEN GETTING CLOSE TO THE TIP OF THE ROTA REX HELIX/TIP THE ROTA REX DEVICE WAS EASILY PUSHED FURTHER DOWN INTO THE LEFT SFA. THE LEFT TO BE MOVED BACK AND FORTH WITHIN THE SFA INDICATING THAT IT WAS NOT UNDERNEATH A STENT STRUT BUT RATHER THE CUP AT THE TIP OF THE ROTA REX DEVICE APPEARED TO BE CAUGHT ON A STENT STRUT PREVENTING ITS REMOVAL. ATTEMPTS WERE MADE TO DELIVER AN ANTEGRADE BALLOON OVER A 0.014 BUDDY WIRE TO DISLODGE THE ROTA REX DEVICE TIP, BUT THIS WAS ALSO UNSUCCESSFUL. THE LEFT DORSALIS PEDIS ARTERY WAS THEN ACCESSED WITH A 5/6 SLENDER SHEATH USING A MICROPUNCTURE KIT. 0.014 WIRE ACCESS BACKUP THE LEFT LEG ALL THE WAY TO THE PROXIMAL SFA WAS ACHIEVED AND A STERLING BALLOON WAS USED TO DISPLACE THE TIP OF THE ROTA REX DEVICE. A 5 MM SNARE WAS THEN USED TO GRAB THE HELIX WITHIN THE CROSSOVER SHEATH AND THE HELIX AND TIP WERE THEN BROUGHT SUCCESSFULLY INTO THE LEFT COMMON FEMORAL AND EXTERNAL ILIAC ARTERY. THE RETROGRADE STERLING BALLOON WAS THEN INFLATED IN THE PROXIMAL SFA TO ACT AS A BACKSTOP AND PREVENT THE HELIX FROM BEING PUSHED BACK DOWN THE LEG AGAIN. THE TRIPLE SNARE SHEATH WAS THEN ADVANCED OVER THE HELIX AND ENGAGED THE TIP AND ALL WAS REMOVED COMPLETELY VIA THE RIGHT FEMORAL SHEATH. MANUFACTURER RESPONSE FOR ROTRAREX (ROTATIONAL EXCISIONAL ATHERECTOMY SYSTEM), ROTRAREX (PER SITE REPORTER) COMPANY REPRESENTATIVES <NAMES REDACTED> PRESENT FOR PROCEDURE AND GIVEN DEVICE. NO FOLLOW-UP AS OF TODAY.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
331171 SET ROTAREX S 6F 135CM (STRAUB MEDICAL) CATHETER, PERIPHERAL, ATHERECTOMY MCW STRAUB MEDICAL AG 80237 240396

Patients

Seq Age Sex Outcome Treatment
1 68 YR Female