MAUDE Adverse Event Report: STRAUB MEDICAL AG ROTAREXS 6F 135CM (STRAUB MEDICAL); ATHERECTOMY CATHETER

Model Number	ROTAREX®S 6F X 135CM
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Embolism (1829); Perforation of Vessels (2135); Vascular Dissection (3160); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Summary evaluation (b)(4).
Event or Problem Description
The doctor used a contralateral approach.It was very hard to pass the stent in the sfa and a.Poplitea.When we passed the stents and are in true lumen in popliteal artery we start to use the rotarex 6f 135cm.We passed the origo of the stent in sfa several times and then the catheter broke.

• Brand Name: ROTAREXS 6F 135CM (STRAUB MEDICAL)
• Common Device Name: ATHERECTOMY CATHETER
• Manufacturer (Section D): STRAUB MEDICAL AG; straubstrasse 12; wangs, sankt gallen 7323 ; SZ 7323
• MDR Report Key: 10138521
• Report Number: 3008439199-2020-00006
• Device Sequence Number: 19438245
• Product Code: MCW
• UDI-Device Identifier: 07640142810278
• UDI-Public: 7640142810278
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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: distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2020

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: 05/17/2022
• Device Model Number: ROTAREX®S 6F X 135CM
• Device Catalogue Number: 80201
• Device Lot Number: 190531
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2020
• Supplement Date Received by Manufacturer: 05/11/2020
• Initial Report FDA Received Date: 06/10/2020
• Supplement Report FDA Received Date: 09/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 85