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

Model Number	ROTAREX®S 6F X 110CM
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Embolism (1829); Perforation of Vessels (2135); No Known Impact Or Consequence To Patient (2692); Vascular Dissection (3160); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Suspect device not returned yet.The return of suspect device is expected.
Event or Problem 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)
• Common Device Name: ATHERECTOMY CATHETER
• Manufacturer (Section D): STRAUB MEDICAL AG; straubstrasse 12; wangs, sankt gallen 7323 ; SZ 7323
• MDR Report Key: 10158002
• Report Number: 3008439199-2020-00007
• Device Sequence Number: 2561405
• Product Code: MCW
• UDI-Device Identifier: 07640142810278
• UDI-Public: 7640142810278
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K172315
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,study,use
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/18/2020

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: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2020
• Supplement Date Received by Manufacturer: 05/18/2020; 05/18/2020
• Initial Report FDA Received Date: 06/16/2020
• Supplement Report FDA Received Date: 07/03/2020; 09/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Weight: 71