MAUDE Adverse Event Report: STRAUB MEDICAL AG ROTAREX®S 6F 110CM (STRAUB MEDICAL®); ATHERECTOMY CATHETER

Model Number ROTAREX®S 6F X 110CM

Device Problems Fracture (1260); Physical Resistance/Sticking (4012)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/16/2020

Event Type  malfunction  

Manufacturer Narrative

Evaluation protocol not completed yet.

Event Description

After a short time (approx.3 min), the catheter got stuck and could no longer be pulled back into the sheath.After recovery of the entire system (catheter with sheath), the whole thing looked as seen.No explanation, no particular difficulties.The catheter could only be retrieved with the sheath after a short use.A new sheath was inserted and the procedure was successfully completed with another catheter.

• Brand Name: ROTAREX®S 6F 110CM (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: 11279820
• MDR Text Key: 231353155
• Report Number: 3008439199-2021-00009
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 07640142810285
• UDI-Public: 7640142810285
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K172315
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/06/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 04/08/2023
• Device Model Number: ROTAREX®S 6F X 110CM
• Device Catalogue Number: 80219
• Device Lot Number: 200771
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2021
• Initial Date Manufacturer Received: 01/06/2020
• Initial Date FDA Received: 02/04/2021
• Supplement Dates Manufacturer Received: 01/06/2020
• Supplement Dates FDA Received: 12/18/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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 Age: 68 YR
• Patient Sex: Female