MAUDE Adverse Event Report: STRAUB MEDICAL AG GUIDEWIRE 0.018 4/220CM ANGLED (STRAUB MEDICAL®); WIRE, GUIDE, CATHETER

Model Number	GUIDEWIRE 0.018 4/220CM ANGLED
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Pain (1994); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Suspect device not returned yet.The return of suspect device is expected.
Event or Problem Description
Doctor was performing a mechanical thrombectomy in a av fistula using rotarex.Rotarex was ran for less than 1 minute when patient stated he was feeling pain.Upon inspection under fluoroscopy, it was noticed that the wire had broken off.Doctor retrieved the broken end with no physical damage to patient.Patient returned to post op in good condition.Doctor was happy with the results.Complained is guidewire gw 0.018" 4/220 cm which is part of set rotarexs 8f 85cm.Further information about set rotarexs 8f 85cm: catalogue number: 80238, lot number: 200137, expiration date (mm/dd/yyy): 01/11/2023, unique identifier (udi) number: (b)(4).

• Brand Name: GUIDEWIRE 0.018 4/220CM 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: 11314703
• Report Number: 3008439199-2021-00011
• Device Sequence Number: 17066768
• Product Code: DQX
• UDI-Device Identifier: 07640142810247
• UDI-Public: 7640142810247
• 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): 01/13/2021

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: 03/31/2024
• Device Model Number: GUIDEWIRE 0.018 4/220CM ANGLED
• Device Catalogue Number: 80233
• Device Lot Number: 91900336
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2021
• Supplement Date Received by Manufacturer: 01/13/2021
• Initial Report FDA Received Date: 02/11/2021
• Supplement Report FDA Received Date: 12/04/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Unknown