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

Model Number SET ROTAREX®S 6F X 135CM

Device Problems Break (1069); Entrapment of Device (1212); Fracture (1260); Material Fragmentation (1261); Defective Device (2588); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Exsanguination (1841); Hemorrhage/Bleeding (1888); Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)

Event Date 03/26/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Event occured (b)(6) 2021 at approximately 8:30am.The case was scheduled for a two hour procedure and ended up taking 6 hours due to the rotarex defect and troubleshooting.After properly preparing the rotarex catheter, entering it through the patients right femoral artery, advancing it up over to 2cm before the left sfa lesion, the device was turned on by using the foot pedal.The bifurcation was not steep or tortuous and was over 4cm in distance.The rotarex was on for approximately 15 seconds when the helix broke off from the catheter.After the catheter was pulled back, about 8 inches of the helix and rotarex head were left free floating in the patients artery.Eventually the helix was retracted from the body.The wire also broke off distally for no known reason, this wire was left in the patient's body.Patient lost a good amount of blood as well as did not receive the therapy he needed that day.Hcp was not content with the rotarex defect and forced to cancel other procedures because he simply did not have time due to the case taking so long.Manufacturer note: complained is also guidewire gw 0.018" 4/320 cm which is part of set rotarexs 6f 135cm.More information about guidewire in the set: further information about guidewire 0.018 4/320cm angled: catalogue number: 80235.Lot number: 92001967.Expiration date (mm/dd/yyy): 05/31/2025.Unique identifier (udi) number: (b)(4).

• Brand Name: ROTAREX®S 6F 135CM (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: 11738940
• MDR Text Key: 247907777
• Report Number: 3008439199-2021-00036
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 07640142810582
• UDI-Public: 7640142810582
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 03/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/09/2023
• Device Model Number: SET ROTAREX®S 6F X 135CM
• Device Catalogue Number: 80237
• Device Lot Number: 200969
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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; Other