MAUDE Adverse Event Report: STRAUB MEDICAL AG ROTAREXS 6F 110CM (STRAUB MEDICAL); ATHERECTOMY CATHETER

Model Number SET ROTAREX®S 6F X 110CM

Device Problems No Flow (2991); No Apparent Adverse Event (3189)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/18/2020

Event Type  malfunction  

Manufacturer Narrative

Evaluation protocol not yet completed.

Event Description

Rotarex 6f 110cm was used to treat the thrombosis in the superficial femoral artery.After rinsing, catheter was inserted into the vessel and start aspiration.No blood was found flowing out from the catheter.Withdraw the catheter, flush again and no liquid was found flowing out.Operation was finally completed by another 6f 110 catheter.

Manufacturer Narrative

Evaluation summary signed on 08/07/2020 attached.

• Brand Name: ROTAREXS 6F 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: 10338679
• MDR Text Key: 242645270
• Report Number: 3008439199-2020-00024
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 07640142810285
• UDI-Public: 7640142810285
• 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: 06/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/20/2023
• Device Model Number: SET ROTAREX®S 6F X 110CM
• Device Catalogue Number: 80219
• Device Lot Number: 200214
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2020
• Date Manufacturer Received: 06/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 72