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

Model Number	503558
Medical Device Problem Codes	Fracture (1260); Difficult to Remove (1528)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/12/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, during a right heart catheterization; the tip of a.018 180cm short sv peripheral steerable guidewire (pgw) had snapped off when the doctor tried to pull back the device as it got stuck in the pulmonary artery (pa).It was then retrieved by a snare and there was no adverse outcome to the patient.There were no reported patient injuries.The procedure was completed once the wire was removed, as there were no further issues.The device was properly stored and opened in sterile field.The device was used in the patient.The product was prepped and handled as per the instructions for use (ifu).The wire was removed from the dispenser by the distal floppy end.The wire was not kinked or damaged in any way prior to insertion into the patient.The wire was re-shaped by the user by curving it on the insertion device.Access was obtained via the right internal jugular vein and there was no resistance encountered at the access site.There was some tortuosity of the pulmonary vessels while tracking the wire before reaching the intended site.The wire did not become fixed or caught at any time prior to the event.The intended vessel was the pulmonary artery and it had no calcification, mild tortuosity.The event occurred while trying to remove the wire as there was resistance felt.The wire tip was visible on fluoro throughout the procedure.There was no difficulty tracking the wire through the vessel.The wire behaved normally, with good torque response.There was no resistance/friction between the wire and other devices.The wire did not kink while being used.The wire was not advanced through the struts of an existing stent.The wire tip did not repeatedly prolapse during placement.The wire tip was advanced into the distal vasculature.The wire was not torqued against resistance.The wire appeared to be lodged or stuck in the distal portion of the pulmonary artery.The physician tried pulling back but there was some resistance.The physician pulled back further (not with excessive amount of force) however, the wire snapped and became frayed.The physician had to use a non-cordis snare device to capture the wire and was subsequently able to remove it from the pulmonary artery (pa) without.The product was not returned for analysis.A product history record (phr) review of lot 35260863 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported events.The reported ¿fractured-separated - in patient¿ and ¿guidewire withdrawal difficulty-from vessel¿ could not be confirmed as the device was not returned for analysis.The exact cause of the reported events could not be conclusively determined.Procedural and patient factors such as vessel tortuosity and the application for excessive force may have contributed the reported events.According to the instructions for use (ifu), which is not intended as a mitigation of risk, ¿guidewire manipulation/torqueing should always be performed under fluoroscopic guidance.Never push, auger, withdraw, or torque a guidewire that meets resistance.First, using fluoroscopy, determine the cause of resistance and take any necessary remedial action.Torqueing 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.If any resistance is felt, i.E., due to vessel spasm, bent guidewire, or guidewire entrapment, while manipulating or removing the guidewire in the blood vessel: stop the procedure.Do not move or torque the guidewire.Using fluoroscopy, first determine the cause of the resistance, then take appropriate remedial action.If the guidewire is moved excessively, it may break or become damaged.This may cause blood vessel injury or result in fragments being left inside the vessel.¿ neither the phr review nor the information available for review suggest that the reported events could be related to the manufacturing process.Therefore, no actions will be taken at this time.
Event or Problem Description
As reported, during a right heart catheterization; the tip.018 180cm short sv peripheral steerable guidewire (pgw) had snapped off when the doctor tried to pull back the device as it got stuck in the pulmonary artery (pa).It was then retrieved by a snare and there was no adverse outcome to the patient.The procedure was completed once the wire was removed, as there were no further issues.No patient injury reported.The device was properly stored and opened in sterile field.The device was used in patient.The product was prepped and handled as per the instructions for use (ifu).The wire was removed from the dispenser by the distal floppy end.The wire was not kinked or damaged in any way prior to insertion into the patient.The wire was re-shaped by the user by curving it on the insertion device.Access was obtained via the right internal jugular vein and there was no resistance encountered at the access site.There was some tortuosity of the pulmonary vessels while tracking the wire before reaching the intended site.The wire did not become fixed or caught at any time prior to the event.The intended vessel was the pulmonary artery and it had no calcification, mild tortuosity.The event occurred while trying to remove the wire as there was resistance felt.The wire tip was visible on fluoro throughout the procedure.There was no difficulty tracking the wire through the vessel.The wire behaved normally, with good torque response.There was no resistance/friction between the wire and other devices.The wire did not kink while being used.The wire was not advanced through the struts of an existing stent.The wire tip did not repeatedly prolapse during placement.The wire tip was advanced into the distal vasculature.The wire was not torqued against resistance.The wire appeared to be lodged or stuck in the distal portion of the pulmonary artery.The physician tried pulling back but there was some resistance.The physician pulled back further (not with excessive amount of force) however, the wire snapped and became frayed.The physician had to use a non cordis snare device to capture the wire and was subsequently able to remove it from the pulmonary artery (pa) without evidence of damage to the vessel.Other procedural details were requested but unknown or unavailable.The device will not be returned because it was discarded by the site.

• 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: 10249906
• Report Number: 1016427-2020-04165
• Device Sequence Number: 2780034
• Product Code: DQX
• UDI-Device Identifier: 20705032056059
• UDI-Public: 20705032056059
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K930091
• Number of Events Summarized: 1
• Summary Report (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): 07/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2021
• Device Model Number: 503558
• Device Catalogue Number: 503558
• Device Lot Number: 35260863
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/12/2020
• Initial Report FDA Received Date: 07/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Weight: 82