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

Model Number SET ROTAREX®S 8F X 110CM

Device Problems Break (1069); Fracture (1260); Physical Resistance/Sticking (4012)

Patient Problems Perforation of Vessels (2135); Rupture (2208)

Event Date 03/17/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

A 6f rotarex s 110cm catheter was being used by doctor for a thrombectomy/atherectomy procedure within the sfa.It was large portion of the vessel being treated in which much of the of it was calcified plaque.The device was working hard to get through the plaque within the sfa.At one point, the guidewire was getting stuck within the catheter and catheter housing itself before the registrar noticed upon pulling out the catheter back that the internal helix had broken and pierced through the catheter itself about half up.A angiograph was then done and it revealed a rupture in the mid sfa.A balloon was then inserted and inflated to see if the vessel would clot enough to close the rupture.After this was done the rupture hadn't completely sealed and a long covered stent was deployed along the sfa.It is our understanding that the patient will be kept in over night for observation.The patient suffered an sfa rupture which meant that a covered stent had to be used which likely wouldn't have used for the procedure.

• 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: 11678680
• MDR Text Key: 245816303
• Report Number: 3008439199-2021-00030
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 07640142810391
• UDI-Public: 7640142810391
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K172315
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/09/2023
• Device Model Number: SET ROTAREX®S 8F X 110CM
• Device Catalogue Number: 80224
• Device Lot Number: 201554
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2021
• Date Manufacturer Received: 03/19/2021
• 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): Hospitalization; Required Intervention