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 Embolism (1829); Perforation of Vessels (2135); No Known Impact Or Consequence To Patient (2692); Vascular Dissection (3160); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/15/2020

Event Type  malfunction  

Manufacturer Narrative

Suspect device not returned yet.The return of suspect device is expected.

Event Description

During the index procedure for pmcf rotarex trial the rotarex head is torn off and could be removed completely without taking further actions.

• 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
• MDR Report Key: 10158002
• MDR Text Key: 195920194
• Report Number: 3008439199-2020-00007
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 07640142810278
• UDI-Public: 7640142810278
• Combination Product (y/n): N
• PMA/PMN Number: K172315
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study,use
• Type of Report: Initial,Followup,Followup
• Report Date: 05/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/07/2023
• Device Model Number: ROTAREX®S 6F X 110CM
• Device Catalogue Number: 80208
• Device Lot Number: 200123
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2020
• Date Manufacturer Received: 05/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Weight: 71