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

Model Number SET ROTAREX®S 8F X 110CM

Device Problems Mechanical Jam (2983); Noise, Audible (3273); Physical Resistance/Sticking (4012)

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

Event Date 05/15/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was realized all the preparation steps before it use.It was used the guide wire 0,018" of the set.The catheter moved to the lesion without any resistance.In the moment of the aspiration, there was a different noise, but the physician continued the aspiration and during if the blood flow to the bag was normally.Before 2 cm to complete the lesion aspiration, the physician noted a vessel rupture, as you can see in the images attached.The time of aspiration was 10 to 15 second until the rupture.The physician removed the catheter and he felt a great resistance.When the catheter was out off the patient, in a attempt to remove the guide wire from the catheter, the physician noted that the guide wire was stuck in the catheter.The vessel rupture was corrected with a balloon and after it was used a coated stent.The patient is doing fine.

Manufacturer Narrative

Evaluation summary signed on (b)(6) 2020 attached.

• 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
• MDR Report Key: 10230946
• MDR Text Key: 197563335
• Report Number: 3008439199-2020-00013
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 07640142810391
• UDI-Public: 7640142810391
• 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,health profession
• Type of Report: Initial,Followup
• Report Date: 06/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/19/2022
• Device Model Number: SET ROTAREX®S 8F X 110CM
• Device Catalogue Number: 80224
• Device Lot Number: 191293
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2020
• Date Manufacturer Received: 06/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR