MAUDE Adverse Event Report: CORDIS CORPORATION PGW .018 SV SHORT 300CM ST; WIRE, GUIDE, CATHETER

Model Number	503558X
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint conclusion: as reported, during preparation the proximal end of a 0.018 300cm straight svp short steerable guidewire became unraveled as it was being manually shaped.As a result, the guidewire was not used in the patent and an unknown guidewire was used to complete the procedure.There was no reported injury to the patient and the device will be returned for evaluation.A non-sterile unit of guidewire ¿pgw.018 sv short 180cm st¿ was received for analysis.The radiopaque distal coil wire was received unraveled.The separated segments were not returned for analysis.Sem results of the separated areas presented evidence of a cup and cone shape and plastic deformation.A product history record (phr) review of lot 35263763 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event the failures reported by the customer as ¿guidewire ~ unraveled/stretched¿ and ¿guidewire~ fractured/separated - during prep¿ were confirmed.A fractured/separated condition was observed on the distal tip and the coil wire was unraveled.Plastic deformations and cup and cone shapes are commonly associated with separations caused by material tensile overload.Therefore, it is assumed that the material of the wires was induced to a tensile force that exceeded the wire material yield strength prior to the separation.Pulling on the distal tip while manually shaping it tip may have contributed to the reported event.Users are trained to inspect for signs of damage prior to and during use.Any product with damage is not to be used.Information for safety is provided in the products labeling with the intent to make the user aware of the risks.According to the instructions for use (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 coil separation, bends, or kinks.Do not use a guidewire that shows signs of damage.Damage will prevent the guidewire from performing with accurate torque response and control.Do not pull the distal tip to remove guidewire from dispenser as it may damage the tip.¿ based on the information available and the phr review, there is no indication that the event is related to the device design or manufacturing process.Therefore, no preventative or corrective actions will be taken at this time.
Event or Problem Description
As reported, during preparation the proximal end of a 0.018 300cm straight svp short steerable guidewire became unraveled as it was being manually shaped.As a result, the guidewire was not used in the patent and an unknown guidewire was used to complete the procedure.There was no reported injury to the patient and the device will be returned for evaluation.Addendum: product evaluation revealed a separated/fractured condition on the distal tip of the core and coil wire.
Additional Manufacturer Narrative
This device is available for analysis, but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.Additional information is pending and will be submitted within 30 days upon receipt.

• Brand Name: PGW .018 SV SHORT 300CM ST
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 14278312
• Report Number: 1016427-2022-05403
• Device Sequence Number: 20133421
• Product Code: DQX
• UDI-Device Identifier: 10705032056069
• UDI-Public: (01)10705032056069(17)230731(10)35263763
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2022

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: 07/31/2023
• Device Model Number: 503558X
• Device Catalogue Number: 503558X
• Device Lot Number: 35263763
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/08/2022
• Supplement Date Received by Manufacturer: 05/04/2022
• Initial Report FDA Received Date: 05/04/2022
• Supplement Report FDA Received Date: 05/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN GUIDEWIRE
• Patient Sex: Unknown