MAUDE Adverse Event Report: CORDIS CORPORATION PGW .018 SV SHORT 180CM ST; WIRE, GUIDE, CATHETER

Model Number	N/A
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A.018¿ 180cm straight (st) sv peripheral steerable guidewire (pgw) has been used with a.018 (non-cordis) intravascular ultrasound (ivus) catheter; however, when the steerable guidewire was being pulled out of the catheter (non-cordis), the wire was noted to be frayed.Physician made sure that there were no leftover materials in the patient.There was no reported patient injury.The operator was trained to use the device.The device was not returned for analysis.As the sterile lot number is unknown, product history record (phr) reviews could not be performed.Based on the information provided, it is not possible to draw a clinical conclusion between the device and the reported event.Without the return of the device for analysis, the reported customer event ¿distal tip-wires- frayed/split/torn - in patient¿ could not be confirmed and the exact root cause could not be determined.Procedural/handling factors may have contributed to the reported event.According to the ifu, although not intended as a mitigation of risk, ¿guidewires are delicate instruments and should be handled carefully.Prior to use and when possible during the procedure, inspect the guidewire carefully for signs of damage.Do not use a guidewire that shows signs of damage.Never push, auger, withdraw, or torque a guidewire that meets resistance.Stop the procedure.Do not move or torque the guidewire.First, using fluoroscopy, determine the cause of resistance and take any necessary remedial action.Torquing or pushing a guidewire against resistance may cause guidewire damage, and/or guidewire tip separation, or direct damage to the vessel.Resistance may be felt and/or observed (via fluoroscopy) by noting any buckling of the guidewire tip.If guidewire tip prolapse is observed, do not allow the tip to remain in a prolapsed position; otherwise damage to the guidewire may occur.¿ without a lot number to conduct a phr review, it is not possible to determine if the reported failure could be related to the manufacturing process.Therefore, no corrective or preventive actions will be taken at this time.
Event or Problem Description
As reported, a.018¿ 180cm straight (st) sv peripheral steerable guidewire (pgw) has been used with a.018 (non-cordis) intravascular ultrasound (ivus) catheter; however, when the steerable guidewire was being pulled out of the catheter (non-cordis), the wire was noted to be frayed.Physician made sure that there were no leftover materials in the patient.There was no reported patient injury.The operator was trained to use the device.The device will not be returned for evaluation.

• Brand Name: PGW .018 SV SHORT 180CM ST
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 11928843
• Report Number: 9616099-2021-04596
• Device Sequence Number: 3181787
• Product Code: DQX
• UDI-Device Identifier: 20705032056059
• UDI-Public: 20705032056059
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K930091
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/03/2021

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 Model Number: N/A
• Device Catalogue Number: 503558
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/11/2021
• Initial Report FDA Received Date: 06/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: .018 PHILIPS IVUS CATHETER