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

Model Number ROTAREX®S 6F X 135CM

Device Problem Fracture (1260)

Patient Problems Embolism (1829); Perforation of Vessels (2135); Vascular Dissection (3160); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/07/2020

Event Type  malfunction  

Manufacturer Narrative

Summary evaluation (b)(4).

Event 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)
• Type of Device: ATHERECTOMY CATHETER
• Manufacturer (Section D): STRAUB MEDICAL AG; straubstrasse 12; wangs, sankt gallen 7323 ; SZ 7323
• MDR Report Key: 10138521
• MDR Text Key: 218268805
• Report Number: 3008439199-2020-00006
• 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: distributor
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 05/11/2020
• Initial Date FDA Received: 06/10/2020
• Supplement Dates Manufacturer Received: 05/11/2020
• Supplement Dates FDA Received: 09/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 85