MAUDE Adverse Event Report: CORDIS CORPORATION INFINITI; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number	534520T
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	02/21/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, the patient fell into anaphylactic shock during a cardiac procedure with the use of a 0.035in fixed-core j- curve 3mm x 175cm emerald diagnostic guidewire, three 5f judkin's left (jl) 4 100cm infiniti diagnostic catheter, and a 5.2f judkin's right (jr) 4 125cm super torque plus diagnostic catheter.There were no reports of patient injury.There was no damage noted to the product packaging upon inspection prior to use.The product was inspected before use and appeared to be normal.No information was provided regarding the actions performed on the guidewire to prepare it for use, but no special problems were detected during the preparation.The guidewire was prepped properly according to the instructions for use (ifu).The device was removed easily and intact from the patient.The cardiac procedure was completed successfully at clinique des grangettes in geneva.The patient's condition is completely stable, and they have been at home for several months.However, they will need to undergo a new procedure in the coming weeks.The devices will not be returned for evaluation as they were used months ago, and the devices are no longer available.
Additional Manufacturer Narrative
Corrected data: previously provided udi is incorrect.Udi for this device is not presently available.
Additional Manufacturer Narrative
Corrected data: udi information was updated.After further review of additional information received the following sections have been updated accordingly: d4, g3, g6, h2, h6, and h10.Complaint conclusion: as reported, the patient fell into anaphylactic shock during a cardiac procedure with the use of a 0.035in fixed-core j- curve 3mm x 175cm emerald diagnostic guidewire, three 5f judkin's left (jl) 4 100cm infiniti diagnostic catheter, and a 5.2f judkin's right (jr) 4 125cm super torque plus diagnostic catheter.There were no reports of patient injury.There was no damage noted to the product packaging upon inspection prior to use.The product was inspected before use and appeared to be normal.No information was provided regarding the actions performed on the guidewire to prepare it for use, but no special problems were detected during the preparation.The guidewire was prepped properly according to the instructions for use (ifu).The device was removed easily and intact from the patient.The cardiac procedure was completed successfully at clinique des grangettes in geneva.The patient's condition is completely stable, and they have been at home for several months.However, they will need to undergo a new procedure in the coming weeks.The devices will not be returned for evaluation as they were used months ago, and the devices are no longer available.The reported event ¿anaphylactic reaction¿ could not be confirmed.Information relating to the patient¿s known allergens was not provided and the devices were not returned to determine if any additional exogenous substances could be identified.Identifying the source of anaphylaxis in a cardiac catheterization lab is challenging due to the numerous potential triggers.However, it is imperative to identify the allergen to prevent a reoccurrence during subsequent procedures.If the allergen is unknown, an allergy work up is essential to determine whether the reaction was caused by a specific product used during the procedure.According to the angiographic catheter and the emerald guidewire instructions for use (ifu), ¿do not use if package is open or damaged.Procedures requiring percutaneous catheter introduction should not be attempted by physicians unfamiliar with the possible complications.¿ based on the available information, 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.
Additional Manufacturer Narrative
Corrected data: section d.4 primary unique device identification (udi) number was verified and updated to: (b)(4).

• Brand Name: INFINITI
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes, florida 33014
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; santiago troncoso 808; juarez, chihuahua ; 7863138372
• MDR Report Key: 19686025
• Report Number: 9616099-2024-00227
• Device Sequence Number: 3212225
• Product Code: DQO
• UDI-Device Identifier: 10705032013680
• UDI-Public: (01)10705032013680(17)260930(10)18252292
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K970854
• 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,Followup,Followup
• Report Date (Section B): 08/08/2024

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: 09/30/2026
• Device Catalogue Number: 534520T
• Device Lot Number: 18252292
• Was Device Available for Evaluation?: No
• 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: 06/10/2024
• Supplement Date Received by Manufacturer: 07/26/2024; 08/07/2024; 08/08/2024
• Initial Report FDA Received Date: 07/07/2024
• Supplement Report FDA Received Date: 08/07/2024; 08/07/2024; 08/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/25/2023
• 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: (3) INFINITI CATHETERS.; EMERALD GUIDEWIRE.; SUPER TORQUE CATHETER.
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Sex: Unknown