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

Model Number SET ROTAREX®S 6F X 135CM

Device Problems Break (1069); Fracture (1260)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/04/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Thrombosis was found in both illiac artery.Introduction was carried out through brachial artery.Catheter was flushed with guildwire before intruding into the human body.After that, catheter reached the 1cm before the lesion.Thrombosis in the left illiac artery was cleared away.Withdraw the catheter for flushing.Tip of the catheter head was found broken and left in the artery.Snare was used to take the remains out.Balloon and thrombolysis catheter were used to complete the operation.

Manufacturer Narrative

Summary evaluation report attached.

• Brand Name: ROTAREXS 6F 135CM (STRAUB MEDICAL)
• Type of Device: ATHERECTOMY CATHETER
• Manufacturer (Section D): STRAUB MEDICAL AG; straubstrasse 12; wangs, sankt gallen 7323 ; SZ 7323
• MDR Report Key: 10850670
• MDR Text Key: 217958810
• Report Number: 3008439199-2020-00060
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 07640142810315
• UDI-Public: 7640142810315
• 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: 10/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/19/2023
• Device Model Number: SET ROTAREX®S 6F X 135CM
• Device Catalogue Number: 80202
• Device Lot Number: 200484
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2020
• Initial Date Manufacturer Received: 10/20/2020
• Initial Date FDA Received: 11/17/2020
• Supplement Dates Manufacturer Received: 10/20/2020
• Supplement Dates FDA Received: 02/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR