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

Model Number	503558
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, the coil on the distal end of a pgw.018 180cm sv st steerable guidewire was found stretched upon removal from the dispenser therefore, the physician could not use it.The procedure was completed by using another sv wire.There were no reports of patient injury.The wire was removed from the dispenser by the distal floppy end.The wire was not used for treatment of another lesion prior to the event.One non-sterile pgw.018 sv short 180cm st unit was received for analysis.During visual inspection, an unraveled/stretched distal tip and a fractured/separated core wire was observed.The core wire was noted to be separated into two pieces.The separated portion of the wire was not returned for analysis.Sem analysis results presented evidence of plastic deformation on the damaged area of the unit.A product history record (phr) review of lot 35263306 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The events ¿distal tip-wires ¿ unraveled/stretched - during prep¿ and "guidewire - fractured/separated" were confirmed because an unraveled/stretched distal tip and a fractured/separated condition on the core wire was noted.Plastic deformations were noted on the damaged area of the wire.These findings are commonly associated with fractures/separations caused by material tensile overload.Therefore, it is assumed that the material of the wire was induced to a tensile force that exceeded the wire material yield strength prior to the separation.Removing the wire from the dispenser by the distal floppy end 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, ¿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, the coil on the distal end of a pgw.018 180cm sv st steerable guidewire was found stretched upon removal from the dispenser; therefore, the physician could not use it.The procedure was completed by using another sv wire.There were no reports of patient injury.The wire was removed from the dispenser by the distal floppy end.The wire was not used for treatment of another lesion prior to the event.The device will be returned for evaluation.Addendum: a fractured/separated condition was noted on the core wire.

• 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
• 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: 15869961
• Report Number: 1016427-2022-05431
• Device Sequence Number: 5258907
• Product Code: DQX
• UDI-Device Identifier: 10705032056052
• UDI-Public: 10705032056052
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/25/2022

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: 04/30/2023
• Device Model Number: 503558
• Device Catalogue Number: 503558
• Device Lot Number: 35263306
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2022
• Initial Report FDA Received Date: 11/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2021
• 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 SV WIRE
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 75 KG