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

Model Number	ROTAREX®S 6F X 110CM
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Codes	Thrombosis (2100); Device Embedded In Tissue or Plaque (3165)
Date of Event	03/25/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Suspect device not returned yet.Return of suspect device is expected.
Event or Problem 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.
Additional Manufacturer Narrative
Evaluation summaty signed on (b)(6) 2020 attached.- attachment: [co200046_fccr_ivyliu_drmowang_shandongprovincialhospital_cn_2020-06-16 scanned.Pdf].
Additional Manufacturer Narrative
Sections b1 and d10 were missing in follow-up_1 report so they are added.

• Brand Name: ROTAREXS 6F 110CM (STRAUB MEDICAL)
• Common Device Name: ATHERECTOMY CATHETER
• Manufacturer (Section D): STRAUB MEDICAL AG; straubstrasse 12; wangs, sankt gallen 7323 ; SZ 7323
• MDR Report Key: 10013263
• Report Number: 3008439199-2020-00004
• Device Sequence Number: 665765
• Product Code: MCW
• UDI-Device Identifier: 07640142810278
• UDI-Public: 7640142810278
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K172315
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2020
• Supplement Date Received by Manufacturer: 04/01/2020; 04/01/2020; 04/01/2020
• Initial Report FDA Received Date: 04/30/2020
• Supplement Report FDA Received Date: 06/26/2020; 07/04/2020; 09/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 85 YR
• Patient Weight: 65