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

Model Number	503558
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is one of two products involved with the reported event.The medical device reporting reference number for these events is 1016427-2021-04932.During use, the.018 x 180cm straight tip sv short peripheral steerable guidewire was stretching.The complaint sv wire was replaced with another.018 x 180cm straight tip sv short peripheral steerable guidewire but the same issue occurred.Additional information was received and the distal tip of the coil wire that should be fused with the core wire was noticed separated.There was no reported patient injury.The procedure was completed with another non-cordis guidewire.This was a pediatric peripheral artery (pa) percutaneous transluminal angioplasty (pta) case.An unknown diagnostic catheter was delivered to the pa.The.018 x 180cm straight tip sv short peripheral steerable guidewire was inserted, however, the position of the distal end and the shaft was out of position and it might have been stretched.It was confirmed by an angiography which was taken before an unknown pta balloon catheter was inserted.The wires were removed from the patient.No other information was provided.One non-sterile guidewire ¿pgw.018 sv short 180cm st¿ was received for analysis.The coil wire presented an unraveled\stretched condition observed at the distal core wire (ribbon).No other damages or anomalies were observed with the naked eye inspection on the returned unit.The distal tip section was analyzed using a vision system to magnify the damaged area.The condition of unraveled was confirmed, and the distal tip of the coil wire that should be fused with the core wire was noticed separated causing this condition.Sem results showed the separated area of the body of the guidewire (sgw.018 sv short 180 cm st) presented evidence of plastic deformation and ductile dimples on the wire of the unit.The plastic deformations and ductile dimples found on wires are commonly associated with separations caused by material tensile overload.Therefore, it is assumed that the material of the guidewire was induced to a tensile force that exceeded the wire material yield strength prior to the separation.No other anomalies were observed during sem analysis.A product history record (phr) review of lot 35260869 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 - in patient¿ and ¿distal tip-wires~ fractured-separated - in patient¿ were confirmed.The distal tip of the coil wire that should be fused with the core wire was noticed separated causing this condition.The cause of these conditions could not be conclusively determined as product analysis results do not suggest that these damages could be related to the manufacturing process.Sem results showed the separated area of the body of the returned sv018 guidewire presented evidence of plastic deformations and ductile dimples on the wire of the unit.The plastic deformations and ductile dimples found on wires are commonly associated with separations caused by material tensile overload.Therefore, it is assumed that the material of the guidewire was induced to a tensile force that exceeded the wire material yield strength prior to the separation.Per the instructions for use, which is 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.¿ neither the phr review nor the product analyses suggest that the observed damages could be related to the manufacturing process of the unit.Lake region medical has no corrective action specific to the product mentioned above and has no preventative action specific to manufacturing this product differently.
Event or Problem Description
During use, the.018 x 180cm straight tip sv short peripheral steerable guidewire (pgw) was stretching.The complaint sv wire was replaced with another.018 x 180cm straight tip sv short peripheral steerable guidewire (pgw) but the same issue occurred.Additional information was received and the distal tip of the coil wire that should be fused with the core wire was noticed separated.There was no reported patient injury.The procedure was completed with another non-cordis guidewire.This was a pediatric peripheral artery (pa) percutaneous transluminal angioplasty (pta) case.An unknown diagnostic catheter was delivered to the pa.The.018 x 180cm straight tip sv short peripheral steerable guidewire (pgw) was inserted, however, the position of the distal end and the shaft was out of position and it might have been stretched.It was confirmed by an angiography which was taken before an unknown pta balloon catheter was inserted.The wires were removed from the patient.The devices will be returned for analysis.No other information was provided.

• Brand Name: PGW .018 SV SHORT 180CM ST
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014
• MDR Report Key: 11719643
• Report Number: 1016427-2021-04933
• Device Sequence Number: 11720957
• Product Code: DQX
• UDI-Device Identifier: 10705032056052
• UDI-Public: 10705032056052
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/23/2021

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 Expiration Date: 12/31/2021
• Device Model Number: 503558
• Device Catalogue Number: 503558
• Device Lot Number: 35260869
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/05/2021
• Initial Report FDA Received Date: 04/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1