MAUDE Adverse Event Report: STRAUB MEDICAL AG GUIDEWIRE 0.018 4/320CM ANGLED (STRAUB MEDICAL); WIRE, GUIDE, CATHETER

Model Number	GUIDEWIRE 0.018 4/320CM ANGLED
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Suspect device not returned yet.The return of suspect device is expected.Further information about set rotarexs 6f 135cm: catalogue number: 80237, lot number: 200664, expiration date (mm/dd/yyy): 04/30/2023, unique identifier (udi) number: (b)(4).
Event or Problem Description
Straight forward case.6f 45 cm flex ansel up and over sheath was used.A.018 staub wire advanced once rotarex usage determined.Rotarex 6f 135 ref #(b)(4) lot# 200541 presented for isr and in between the 2 sfa/pop stents.Doc aware of off label indication.Dr.Carter treated the 2 stents and the gap in between stents.During procedure the rotarex clutched out one time, doc backed up and reengaged lesion.Terrific results.Removed rotarex and inspected.Intact.Upon introducing an ultraverse 5x150 pta, pta wouldn't advance.Noticed the proximal tip of wire had fractured.The fractured portion of the proximal 30cm portion of wire was in the proximal sfa.Physician snared wire portion with no complication.Case was completed with.035 wire, pta and stenting.Excellent result.Physician said absolutely no issue with device.Comlained is guidewire which is part of set rotarexs 6f 135cm.
Additional Manufacturer Narrative
Device was discarded at the hospital.Investigation was performed without the device.

• Brand Name: GUIDEWIRE 0.018 4/320CM 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: 10791442
• Report Number: 3008439199-2020-00053
• Device Sequence Number: 3211433
• Product Code: DQX
• UDI-Device Identifier: 07640142810261
• UDI-Public: 7640142810261
• 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): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2020

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: 01/31/2025
• Device Model Number: GUIDEWIRE 0.018 4/320CM ANGLED
• Device Catalogue Number: 80235
• Device Lot Number: 200600
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2020
• Supplement Date Received by Manufacturer: 09/30/2020
• Initial Report FDA Received Date: 11/05/2020
• Supplement Report FDA Received Date: 01/07/2021
• 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: Required Intervention
• Patient Age: 77 YR
• Patient Weight: 54