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

Model Number	ROTAREX®S 8F X 85CM
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Device Damaged by Another Device (2915)
Health Effect - Clinical Codes	Device Embedded In Tissue or Plaque (3165); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was discarded at the hospital.Investigation will be performed without the device.
Event or Problem 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®)
• Common Device Name: 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
• Report Number: 3008439199-2021-00018
• Device Sequence Number: 17277289
• Product Code: MCW
• UDI-Device Identifier: 07640142810599
• UDI-Public: 7640142810599
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K172315
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2021
• Supplement Date Received by Manufacturer: 02/09/2021
• Initial Report FDA Received Date: 03/11/2021
• Supplement Report FDA Received Date: 11/12/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown