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

Model Number ROTAREX®S 8F X 110CM

Device Problems Break (1069); Fracture (1260); Material Rupture (1546); Obstruction of Flow (2423)

Patient Problems Foreign Body In Patient (2687); Insufficient Information (4580)

Event Date 12/15/2020

Event Type  Injury  

Manufacturer Narrative

Evaluation protocol not completed yet.

Event Description

C/o with sheath destination 8f, 45cm from terumo.Initially everything normal, then short stop with signal and breakage of the shaft.The system then had to be surgically removed.Initially, completely normal course of thrombectomy.Until the time of sudden blockage and rupture of the catheter (after approx.4 min).

• Brand Name: ROTAREX®S 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: 11280132
• MDR Text Key: 230308594
• Report Number: 3008439199-2021-00010
• 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: Health Professional,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/30/2023
• Device Model Number: ROTAREX®S 8F X 110CM
• Device Catalogue Number: 80224
• Device Lot Number: 201271
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2021
• Date Manufacturer Received: 01/06/2021
• 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 Sex: Male