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

Catalog Number	502585
Medical Device Problem Codes	Material Frayed (1262); Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: phone number-(b)(6).This device is available for analysis, but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, the coating of the.035 fixed core j3mm 175cm diagnostic guidewire was cut at the end.A fragment of wire was emerging from the coating at the end of the device.It was noted that the wire inside the guidewire/coating was cut.The physician felt friction while entering the guidewire into the diagnostic catheter, which led him to refrain from pushing the guidewire further into the patient.Instead, he removed it and used a new wire of the same catalog.There was no reported injury to the patient.The product was stored on a shelf in its box, and no anomalies were noted when the device was taken out of the package.The damage was noticed when the guidewire was first inserted into the diagnostic catheter at the beginning of the procedure.The device is being returned for evaluation.It is confirmed that the device was not used to attempt passing a heavily calcified lesion, and details regarding the lesion¿s location and vessel tortuosity are unknown.The device will be returned for evaluation.There are no images available to show the wire damage.
Event or Problem Description
As reported, the coating of the.035 fixed core j3mm 175cm diagnostic emerald guidewire was cut at the end.A fragment of wire was emerging from the coating at the end of the device.It was noted that the wire inside the guidewire/coating was cut.The physician felt friction while entering the guidewire into the diagnostic catheter, which led him to refrain from pushing the guidewire further into the patient.Instead, he removed it and used a new wire of the same catalog.There was no reported injury to the patient.The product was stored on a shelf in its box, and no anomalies were noted when the device was taken out of the package.The damage was noticed when the guidewire was first inserted into the diagnostic catheter at the beginning of the procedure.The device is being returned for evaluation.It is confirmed that the device was not used to attempt passing a heavily calcified lesion, and details regarding the lesion¿s location and vessel tortuosity are unknown.The device will be returned for evaluation.There are no images available to show the wire damage.
Additional Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly: b5, g3, g6, h1, h2, h3, h6, and h11.As reported, the coating of the.035 fixed core j3mm 175cm diagnostic emerald guidewire was cut at the end.A fragment of wire was emerging from the coating at the end of the device.It was noted that the wire inside the guidewire/coating was cut.The physician felt friction while entering the guidewire into the diagnostic catheter, which led him to refrain from pushing the guidewire further into the patient.Instead, he removed it and used a new wire of the same catalog.There was no reported injury to the patient.The product was stored on a shelf in its box, and no anomalies were noted when the device was taken out of the package.The damage was noticed when the guidewire was first inserted into the diagnostic catheter at the beginning of the procedure.It is confirmed that the device was not used to attempt passing a heavily calcified lesion, and details regarding the lesion¿s location and vessel tortuosity are unknown.A non-sterile unit of guidewire dgw.035 fc j3mm 175cm tef was received coiled inside of a clear plastic bag.The device was unpacked to proceed with the product evaluation.During the visual inspection, the guidewire was noted to be kinked/bent (damaged).The damage was located approximately 3.5 cm from the distal tip.No other damages or anomalies were observed on the returned unit after a thorough inspection.A functional analysis was performed to determine if an impediment to advance the wire into a lab sample unit was noted, and the resistance/friction was confirmed since the wire could not advance freely through the unit.Due to the damaged condition noted on the visual review, amplified images were taken to review it, and it was observed that the core wire was exposed through the damaged (torn) coiled wire.The condition observed was analyzed from the inside of the elongation of the coiled wire and no anomalies were noted on the core wire or on the coiled wire.The reported event by the customer as ¿guidewire - resistance/friction¿ was confirmed since during functional analysis resistance/friction was felt since the wire could not advance freely through the unit.This is most likely due to the damages condition found on the unit, since the core wire was found exposed through the coiled wire.The reported event by the customer as ¿distal tip- frayed/split/torn¿ and ¿guidewire - exposed braidwire/corewire¿ were confirmed since a torn condition was noted on the coiled wire that exposed the core wire.Procedural and/or handling factors might have contributed to the conditions reported/found 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.It is possible that the resistance reported caused excessive force on the catheter, which caused it to buckle and kink.Consequently, the excessive bend of the kink may then have led to the torn condition that exposed the core/coiled wires.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.Interference or friction between devices (including all catheters, wires, sheath introducers, balloon/sds catheters) whether between one or multiple manufacturers product lines is a known occurrence.If resistance is encountered the system should be withdrawn together as one unit to prevent injury.This is a common practice during and is stated in the product instructions for use (ifu).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.

• Brand Name: EMERALD
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): CORDIS US. CORP; 14201 nw 60 avenue 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: 20282158
• Report Number: 1016427-2024-00030
• Device Sequence Number: 18033361
• Product Code: DQX
• UDI-Device Identifier: 10705032055598
• UDI-Public: (01)10705032055598(17)270531(10)35271219
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2024

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: 502585
• Device Lot Number: 35271219
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2024
• 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: 11/04/2024
• Initial Report FDA Received Date: 09/23/2024
• Supplement Report FDA Received Date: 11/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/13/2024
• 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