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

Model Number ROTAREX®S 6F X 110CM

Device Problems Break (1069); Fracture (1260)

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

Event Date 03/22/2021

Event Type  malfunction  

Manufacturer Narrative

Evaluation protocol not completed yet.

Event Description

Using 2 rotarex catheters and with both, same thing happened, catheter broke inside and the tip went off.The issue with previous catheter was resolved using this rotarex.After, this also showed the same problem, intervention was stopped unfinished.Manufacturer note: previous complained catheter was reported under 3008439199-2021-00034.

• Brand Name: ROTAREXS 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: 11738613
• MDR Text Key: 250214032
• Report Number: 3008439199-2021-00035
• 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: distributor,health profession
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/23/2021
• Device Model Number: ROTAREX®S 6F X 110CM
• Device Catalogue Number: 80219
• Device Lot Number: 201600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2021
• Date Manufacturer Received: 03/29/2021
• 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: 78 YR