MAUDE Adverse Event Report: STRAUB MEDICAL AG SET ROTAREX S 6F 135 CM; CATHETER, PERIPHERAL, ATHERECTOMY

Model Number 80237

Device Problems Device Dislodged or Dislocated (2923); Physical Resistance/Sticking (4012)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 06/24/2020

Event Type  Injury  

Event Description

Vascular surgeon approached by bard to bring in this product to use.The bard reps were in the room.Recently approved to be used in us by fda.The patient was undergoing angiographic atherectomy using the rotarex device when the helix and burr disarticulated from the catheter device.The helix was prolapsed into the aorta and attempt at endosalvage was performed with a snare.This was attempted to be removed from the left groin, however, it was completely stuck within the calcium of the right lower extremity.Conversion to open extraction was performed for the right groin, however, the patient had significant drop in blood pressure and was concerned of intra-abdominal injury.Crash laparotomy was performed with aortic cross clamping.Fda safety report id# (b)(4).

• Brand Name: SET ROTAREX S 6F 135 CM
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): STRAUB MEDICAL AG; minneapolis MN 55426
• MDR Report Key: 10239411
• MDR Text Key: 197997986
• Report Number: MW5095392
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 07/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: 80237
• Device Lot Number: 200475
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2020
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 74 YR