MAUDE Adverse Event Report: STRAUB MEDICAL AG ROTAREX®S 8F 85CM (STRAUB MEDICAL®); ATHERECTOMY CATHETER

Model Number ROTAREX®S 8F X 85CM

Device Problems Loss of or Failure to Bond (1068); Entrapment of Device (1212); Overheating of Device (1437); Difficult to Remove (1528); Device Damaged by Another Device (2915); Material Deformation (2976)

Patient Problems Device Embedded In Tissue or Plaque (3165); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/05/2021

Event Type  malfunction  

Manufacturer Narrative

Device was discarded at the hospital.Investigation will be performed without the device.

Event Description

Doctor was performing a declot.At or around 1 minute of running the rotarex, the scrub tech stated that the wire was feeling hot.I asked doctor to stop and reassess which he did.As he was removing the catheter he felt that the wire was hard to manipulate.After he finally removed the catheter and wire, he noticed that the tip of the wire was mangled.He used fluoroscopy to search for any wire fragments upon which he located.After multiple attempts to retrieve wire fragment it was determined that there was no immediate or future harm to the patient and decided to continue with the completion of the procedure.

• Brand Name: ROTAREX®S 8F 85CM (STRAUB MEDICAL®)
• Type of Device: ATHERECTOMY CATHETER
• Manufacturer (Section D): STRAUB MEDICAL AG; straubstrasse 12; wangs, sankt gallen 7323 ; SZ 7323
• Manufacturer (Section G): STRAUB MEDICAL AG; straubstrasse 12; wangs, sankt gallen 7323 ; SZ 7323
• Manufacturer Contact: martin kvokacka ; straubstrasse 12; wangs, sankt gallen 7323 ; SZ 7323
• MDR Report Key: 11462036
• MDR Text Key: 241104132
• Report Number: 3008439199-2021-00018
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 07640142810599
• UDI-Public: 7640142810599
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172315
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/11/2023
• Device Model Number: ROTAREX®S 8F X 85CM
• Device Catalogue Number: 80238
• Device Lot Number: 200137
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention