MAUDE Adverse Event Report: STRAUB MEDICAL AG GUIDEWIRE 0.018 4/270CM ANGLED (STRAUB MEDICAL®)

Model Number	GUIDEWIRE 0.018 4/270CM ANGLED
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was discarded at the hospital.Investigation will be performed without the device.Lot number of guidewire and catheter unknown.Expiry date of guidewire unknown.
Event or Problem Description
Fracture of the wire during operation in stent occlusion sfa.Complained is guidewire gw 0.018" 4/270 cm which is part of set rotarexs 6f 110cm.More information about this set are following: further information about set rotarexs 6f 110cm: catalogue number: 80219, lot number: unknown, expiration date (mm/dd/yyy): 21.02.2023, unique identifier (udi) number: (b)(4).
Additional Manufacturer Narrative
Added additional data to b5 and d4.This follow-up report was reported initially on 08/14/2021 under 3008439199-2021-00029_1 and not as 3008439199-2021-00023_1.This accident was discovered today (12/18/2021) and now it was correctly reported under 3008439199-2021-00023_1.
Event or Problem Description
Further information about set rotarexs 6f 110cm: catalogue number: 80219, lot number: 201554, expiration date (mm/dd/yyyy): 21.02.2023, unique identifier (udi) number: (b)(4).

• Brand Name: GUIDEWIRE 0.018 4/270CM ANGLED (STRAUB MEDICAL®)
• Common Device Name: GUIDEWIRE
• 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: 11580068
• Report Number: 3008439199-2021-00023
• Device Sequence Number: 2998719
• Product Code: DQX
• UDI-Device Identifier: 07640142810254
• UDI-Public: 7640142810254
• Combination Product (Y/N): N
• Initial Reporter Country: EG
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2021

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: 06/30/2025
• Device Model Number: GUIDEWIRE 0.018 4/270CM ANGLED
• Device Catalogue Number: 80234
• Device Lot Number: 92001972
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2021
• Supplement Date Received by Manufacturer: 02/25/2021
• Initial Report FDA Received Date: 03/27/2021
• Supplement Report FDA Received Date: 12/18/2021
• 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
• Patient Age: 45 YR
• Patient Sex: Male