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

Model Number SET ROTAREX®S 6F X 110CM

Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Perforation of Vessels (2135); Vascular Dissection (3160)

Event Date 06/16/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The second cases was from a up and over approach using a 6fr.Terumo sheath.Patient had two lesions, one in mid sfa and a popliteal 90% stenosis.Wire placement was confirmed intraluminal via ivus.Setup of device was performed - no problems.Rtx performed well in the first segment of the lesion.Popliteal lesion rtx created a fistula.Dr.(b)(6) then used a 3 minute balloon inflation to tack up the dissection.

Manufacturer Narrative

Summary evaluation report attached.Added data to d8 and d9 and correction of initial reporter.

• 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: 10240648
• MDR Text Key: 197826160
• Report Number: 3008439199-2020-00018
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 07640142810575
• UDI-Public: 7640142810575
• Combination Product (y/n): N
• PMA/PMN Number: K172315
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/13/2023
• Device Model Number: SET ROTAREX®S 6F X 110CM
• Device Catalogue Number: 80236
• Device Lot Number: 200135
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention