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	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Insufficient Information (4580)
Date of Event	12/04/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Suspect device not returned yet.The return of suspect device is expected.
Event or Problem Description
After he ran rotarex and was trying to remove the catheter he was having some issue with it being a little snug coming out of the sheath.Doctor who was another attending in the case, clamped the wire with forceps and they finally were able to remove the catheter.After the removal, they took a fluoroscopy picture and determined the tip of the wire had broken off.The tip was not impeding any flow so they came to a agreement to place a covered stent in the area of the broken wire.Comlained 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: unknown, expiration date (mm/dd/yyy): unknown, (b)(4).
Event or Problem Description
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
• MDR Report Key: 11134937
• Report Number: 3008439199-2021-00002
• Device Sequence Number: 11320595
• 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: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2020

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: 03/31/2024
• 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: 12/09/2020
• Supplement Date Received by Manufacturer: 12/09/2020
• Initial Report FDA Received Date: 01/07/2021
• Supplement Report FDA Received Date: 04/26/2021
• 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: Other; Required Intervention