MAUDE Adverse Event Report: CORDIS US CORP. SV018; WIRE, GUIDE, CATHETER

Catalog Number	503558
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, the ¿coil part¿ of a 0.018" straight tip sv short 180cm peripheral steerable guidewire (pgw) got stretched during use, the complaint device was replaced with another unknown device and the procedure continued.There was no reported patient injury.The device was being used in a pediatric percutaneous transluminal angioplasty (pta) case.One non-sterile unit of a pgw.018 sv short 180cm st was received for evaluation.During visual inspection, the unit was noted to be separated into two parts at the distal tip.No other damages or anomalies were observed during visual inspection.Sem analysis presented evidence of increased surface roughness, elongations, and striation patterns near the separated sections.A product history record (phr) review of lot 35264005 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The complaint reported by the customer as ¿guidewire-unraveled/stretched¿ was not confirmed.This condition was not observed.However, the malfunction ¿guidewire -fractured-separated¿ was confirmed.The wire was separated into two pieces.The increased surface roughness, elongations and striation patterns identified near the separated sections are commonly associated with plastic deformation, which occurs when materials are exposed to excessive mechanical stress.This happens when the resistance properties are overloaded resulting in fatigue failure.The exact cause of these findings cannot be conclusively determined during the analysis however, handling factors and/or patient vessel characteristics may be contributing factors.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, ¿cordis guidewires are intended for use in angiographic procedures to introduce and position catheters and interventional devices within the peripheral vasculature.Never advance, withdraw or auger the guidewire against resistance without first determining the cause of resistance under fluoroscopy.Torquing the guidewire against resistance may cause damage and/or fracture which may result in separation of the distal tip.Do not pull the distal tip to remove guidewire from dispenser as it may damage the tip.Tip fractures have been reported in procedures involving total occlusions, highly tortuous vasculature, and small side branches.¿ 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 part¿ of a 0.018" straight tip sv short 180cm peripheral steerable guidewire (pgw) got stretched during use, the complaint device was replaced with another unknown device and the procedure continued.There was no reported patient injury.The device was being used in a pediatric percutaneous transluminal angioplasty (pta) case.Multiple attempts to obtain supplemental information were made; however, additional event details were not provided.The device was expected to be returned for evaluation; however, no product return information was provided.

• Brand Name: SV018
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): CORDIS US CORP.; 14201 nw 60th avenue; miami lakes 33014
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes, florida 33014
• Manufacturer Contact: karla castro ; butlersland new ross co.; wexford, ireland Y34 ; EI Y34 ; 7863138372
• MDR Report Key: 18097237
• Report Number: 9681477-2023-00123
• Device Sequence Number: 14899958
• Product Code: DQX
• UDI-Device Identifier: 10705032056052
• UDI-Public: (01)10705032056052(17)230831(10)35264005
• 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): 11/08/2023

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: 08/31/2023
• Device Catalogue Number: 503558
• Device Lot Number: 35264005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2023
• Initial Report FDA Received Date: 11/08/2023
• Date Device Manufactured: 09/27/2021
• 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: UNK DEVICE
• Patient Sex: Unknown