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

Model Number ROTAREX®S 6F X 110CM

Device Problems Break (1069); Mechanical Jam (2983)

Patient Problems Thrombosis (2100); Device Embedded In Tissue or Plaque (3165)

Event Date 03/25/2020

Event Type  Injury  

Manufacturer Narrative

Suspect device not returned yet.Return of suspect device is expected.

Event Description

Thrombosis was found in sfa.Anterograde puncture was performed.Straub guidewire was used.Syringe was used to flush the catheter before inserting into the body.Guidewire reached 15cm beyond the thrombosis.Catheter reached 2cm before the thrombosis and started the motor.At the beginning, blood was found flowing out.After around one minute, no blood flow was found.Big resistance was found when taking it out.About 10cm of the catheter head was left in the vessel.Knife and scissors were used to take the broken head out.Another new catheter was used to complete the operation.

Manufacturer Narrative

Evaluation summaty signed on (b)(6) 2020 attached.- attachment: [co200046_fccr_ivyliu_drmowang_shandongprovincialhospital_cn_2020-06-16 scanned.Pdf].

Manufacturer Narrative

Sections b1 and d10 were missing in follow-up_1 report so they are added.

• 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: 10013263
• MDR Text Key: 189985357
• Report Number: 3008439199-2020-00004
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 07640142810278
• UDI-Public: 7640142810278
• 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
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/13/2022
• Device Model Number: ROTAREX®S 6F X 110CM
• Device Catalogue Number: 80208
• Device Lot Number: 190253
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2020
• Date Manufacturer Received: 04/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 85 YR
• Patient Weight: 65