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

Catalog Number	502455
Medical Device Problem Codes	Material Frayed (1262); Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, the.035 x 260 fixed core j3mm diagnostic guidewire came split out of the body.The damage was noticed after sheath placement, when the device was removed.A new wire was used to complete the procedure.There is no reported injury to the patient.No images are available showing the wire damage.The product was stored in the lab with the package hung up, and no damage was noted to the package.No anomalies were observed when the device was taken out of the package.There was no resistance or friction while inserting the wire through the sheath or advancing through the vessel.The device was not used to pass a heavily calcified lesion.The vessel was not specified, but it was not tortuous.The device will be returned for evaluation.
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 Manufacturer Narrative
As reported, the.035 x 260 fixed core j3mm diagnostic guidewire came split out of the body.The damage was noticed after sheath placement, when the device was removed.A new wire was used to complete the procedure.There is no reported injury to the patient.No images are available showing the wire damage.The product was stored in the lab with the package hung up, and no damage was noted to the package.No anomalies were observed when the device was taken out of the package.There was no resistance or friction while inserting the wire through the sheath or advancing through the vessel.The device was not used to pass a heavily calcified lesion.The vessel was not specified, but it was not tortuous.One non-sterile ¿dgw.035 fc j3mm 260cm tef¿ was received inside a clear plastic bag.The device was unpacked to initiate the product evaluation process.Upon examination, the mini guidewire was observed to be unraveled and exhibited a stretched condition.No frayed, split, or torn conditions were detected at the distal tip during the assessment.Additionally, it was noted that there was evidence of an exposed braid wire/core wire.Visual inspection at high magnification revealed that the guidewire was unraveled and exhibited a stretched condition.These characteristics are typically indicative of unraveled or stretched conditions resulting from material tensile overload.No other anomalies were observed during the microscopic analysis.Furthermore, sem analysis was not conducted because the conditions of the exposure of the braided wire and core wire, as well as the stretched condition of the received device, are clearly visible with the magnification provided by the vision system, as well as during the visual analysis.Based on the information provided, the condition of the returned device and the investigation performed, the failure reported as distal tip-frayed/split/torn- was not confirmed, since no evidence of frayed/split/torn conditions were noted in the distal tip.In addition, the failure reported as ¿guidewire- exposed braidwire/corewire¿ was confirmed due to the guidewire being unraveled and due to it exhibiting a stretched condition, with an exposed braidwire/corewire.Therefore, it is assumed that the material of the device was induced to a tensile force that exceeded the wire material yield strength prior to the unraveled and exhibited a stretched condition.Procedural and/or handling factors might have contributed to the condition reported on the unit since the device did not present any obvious indication of manufacturing defect or anomaly that could contribute to the event as reported.The exact cause could not be determined.Factors such as vessel anatomy and handling factors could have led to the reported event, as it can lead to excessive catheter manipulation.All catheters require torquing, which is a dynamic process once it enters the patient due to external factors such as temperature, time of exposure in body, individual patient anatomical structures, storage conditions, and operator technique in torquing and manipulating the catheter.If a catheter does not move as expected, the operator is trained to stop and investigate the cause before continuing the product analysis does not suggest that the reported failure could be related to the manufacturing process of the unit.No corrective or preventive actions will be taken.
Event or Problem Description
As reported, the.035 x 260 fixed core j3mm diagnostic guidewire came split out of the body.The damage was noticed after sheath placement, when the device was removed.A new wire was used to complete the procedure.There is no reported injury to the patient.No images are available showing the wire damage.The product was stored in the lab with the package hung up, and no damage was noted to the package.No anomalies were observed when the device was taken out of the package.There was no resistance or friction while inserting the wire through the sheath or advancing through the vessel.The device was not used to pass a heavily calcified lesion.The vessel was not specified, but it was not tortuous.The device will be returned for evaluation.

• Brand Name: EMERALD
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): CORDIS US. CORP; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; butlersland new ross co.; wexford ; 7863138372
• MDR Report Key: 20281171
• Report Number: 1016427-2024-00029
• Device Sequence Number: 20686614
• Product Code: DQX
• UDI-Device Identifier: 10705032055031
• UDI-Public: (01)10705032055031(17)270331(10)35270634
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K864058
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• 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): 11/08/2024

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
• Device Catalogue Number: 502455
• Device Lot Number: 35270634
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2024
• 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: Not provided
• Supplement Date Received by Manufacturer: 10/15/2024
• Initial Report FDA Received Date: 09/23/2024
• Supplement Report FDA Received Date: 11/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/23/2024
• 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.
• Patient Sex: Unknown