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 Stretched (1601); Difficult to Advance (2920); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Vascular Dissection (3160); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/05/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

There was a case on (b)(6) 2021, patient was punctured at right femoral artery and crossover to left proximal sfa in stent occlusion and heparin were gaved 5,000 iu as initial and repeat heparin 1,000 iu every hour.Doctor has choose rotarex 6f 135 cm , at first run rotarex ,he felt something not smooth and for second pass seem like catheter could not run passed through the clot.Finally he decided to remove the catheter and find out that tip of the catheter was stretch from catheter.Then change to new catheter , rotarex 6f 135cm with 3 passes and pta balloons.Finally patient got the flow in sfa.

• 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: 11633298
• MDR Text Key: 260126495
• Report Number: 3008439199-2021-00028
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 07640142810315
• UDI-Public: 7640142810315
• Combination Product (y/n): N
• Reporter Country Code: TH
• 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: 03/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2023
• Device Model Number: SET ROTAREX®S 6F X 135CM
• Device Catalogue Number: 80202
• Device Lot Number: 201295
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2021
• Date Manufacturer Received: 03/11/2021
• 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 Age: 59 YR
• Patient Sex: Male