MAUDE Adverse Event Report: STRAUB MEDICAL AG GUIDEWIRE 0.018 4/270CM ANGLED (STRAUB MEDICAL®); WIRE, GUIDE, CATHETER

Model Number	GUIDEWIRE 0.018 4/270CM ANGLED
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation protocol not completed yet.
Event or Problem Description
Rotarex wire broke.Patient had 8cm pop cto.Doc got left cfa access and went up and over.Crossed cto very easily.Placed 6fr cook up and over sheath.Placed.018 rotarex across lesion.Ran the device for two passes in the cto.Took the device out and the lesion look great.Doc wanted to exchange for a different 018 wire to balloon.Placed cxi cook catheter down and removed the rotarex wire.The doc realized the wire did not feel right.Looked at what should of been the distal tip and it was sharp.Looked under xray to see that a part of the wire was still in the patient.He had to snare the wire to get it out.Complained is guidewire gw 0.018" 4/270 cm which is part of set rotarexs 6f 110cm.Further information about set rotarexs 6f 110cm: catalogue number: 80236.Lot number: 201177.Expiration date (mm/dd/yyy): 09/08/2023.Unique identifier (udi) number: (b)(4).

• Brand Name: GUIDEWIRE 0.018 4/270CM ANGLED (STRAUB MEDICAL®)
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): STRAUB MEDICAL AG; straubstrasse 12; wangs, sankt gallen 7323 ; SZ 7323
• Manufacturer (Section G): STRAUB MEDICAL AG; straubstrasse 12; wangs, sankt gallen 7323 ; SZ 7323
• Manufacturer Contact: martin kvokacka ; straubstrasse 12; wangs, sankt gallen 7323 ; SZ 7323
• MDR Report Key: 11608959
• Report Number: 3008439199-2021-00025
• Device Sequence Number: 3355997
• Product Code: DQX
• UDI-Device Identifier: 07640142810254
• UDI-Public: 7640142810254
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K172315
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2021

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: 05/31/2025
• Device Model Number: GUIDEWIRE 0.018 4/270CM ANGLED
• Device Catalogue Number: 80234
• Device Lot Number: 92001973
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2021
• Supplement Date Received by Manufacturer: 03/05/2021
• Initial Report FDA Received Date: 04/02/2021
• Supplement Report FDA Received Date: 12/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male