MAUDE Adverse Event Report: STRAUB MEDICAL AG ROTAREXS 8F 110CM (STRAUB MEDICAL); ATHERECTOMY CATHETER

Model Number ROTAREX®S 8F X 110CM

Device Problems Use of Device Problem (1670); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/24/2020

Event Type  malfunction  

Manufacturer Narrative

Summary evaluation was translated from (b)(6) to english language.

Event Description

Long left sfa lesion.Cross over with 8f dura sheath.Treatment with 8f rotarex.When pulling back the rotarex dr.Tessarek noticed that a part of the helix and rotarex head was separated.Separated part was snared into the sheath.

• Brand Name: ROTAREXS 8F 110CM (STRAUB MEDICAL)
• Type of Device: ATHERECTOMY CATHETER
• Manufacturer (Section D): STRAUB MEDICAL AG; straubstrasse 12; wangs, sankt gallen 7323 ; SZ 7323
• Manufacturer (Section G): STRAUB MEDICAL AG; straubstrasse 12; wangs, sankt gallen 7323 ; SZ 7323
• Manufacturer Contact: martin kvokacka ; straubstrasse 12; wangs, sankt gallen 7323 ; SZ 7323
• MDR Report Key: 10770170
• MDR Text Key: 214149304
• Report Number: 3008439199-2020-00052
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 07640142810391
• UDI-Public: 7640142810391
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K172315
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/07/2023
• Device Model Number: ROTAREX®S 8F X 110CM
• Device Catalogue Number: 80224
• Device Lot Number: 200790
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2020
• Date Manufacturer Received: 10/05/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR