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

Model Number	ROTAREX®S 6F X 110CM
Medical Device Problem Codes	Fracture (1260); Use of Device Problem (1670)
Health Effect - Clinical Codes	Embolism (1829); Perforation of Vessels (2135); Vascular Dissection (3160); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of device is completed and signed on 09-apr-2020, but written in (b)(6) language.This will be translated to english and will be sent in follow-up report.
Event or Problem Description
Slim patient.Left antegrade approach with occlusion to trunk.Helix has broken during a second pass.This was noticed at the end.The procedure was completed.It was a third pass which could not be done.The result was ok.Helix could be removed from the patient by pulling out the sheath.
Additional Manufacturer Narrative
Added data to d8 and d9 and correction of h6.
Additional Manufacturer Narrative
Erroneous catalog number value "80219" change to correct catalog number value "80208".
Additional Manufacturer Narrative
- attachment: [co200045_fccr_arminbirrer_dr.Fasihi_ksolten_ch_2020-04-28_english.Pdf, co200045_fccr_arminbirrer_dr.Fasihi_ksolten_ch_2020-04-08_scanned.Pdf].

• 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: 9997351
• Report Number: 3008439199-2020-00003
• Device Sequence Number: 4597662
• Product Code: MCW
• UDI-Device Identifier: 07640142810278
• UDI-Public: 7640142810278
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 03/25/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/20/2022
• Device Model Number: ROTAREX®S 6F X 110CM
• Device Catalogue Number: 80208
• Device Lot Number: 190980
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2020
• Supplement Date Received by Manufacturer: 03/25/2020; 03/25/2020; 03/25/2020
• Initial Report FDA Received Date: 04/24/2020
• Supplement Report FDA Received Date: 04/28/2020; 04/30/2020; 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