MAUDE Adverse Event Report: COOK INC MREYE EMBOLIZATION COIL; KRD DEVICE, EMBOLIZATION, VASCULAR

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); High Blood Pressure/ Hypertension (1908); Rash (2033); Swelling/ Edema (4577)
Date of Event	05/13/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.E1 - customer (person): phone: (b)(6).This report includes information known at this time.A follow-up report will be submitted should additional, relevant information become available.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned or that a death or serious injury occurred; nor is it admission that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
It was reported that following placement of two mreye embolization coils an allergic reaction occurred.The coils were placed in the patient on (b)(6) 2023.Five days after placement, the patient reported persistent high blood pressure, rash, and swelling.The patient underwent multiple medical appointments, blood tests, scans, and a skin patch test.It was determined the patient was allergic to four metal elements.Subsequently, the coils were later removed.No other adverse effects were reported for this incident.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation ¿ evaluation.It was reported that following placement of two mreye embolization coils an allergic reaction occurred.The coils were placed in the patient on (b)(6) 2023 to treat a varicocele.Five days after placement, the patient reported persistent high blood pressure, rash, and swelling.The patient underwent multiple medical appointments, blood tests, scans, and a skin patch test.It was determined the patient was allergic to four metal elements.Subsequently, the coils were removed in an additional procedure.No other adverse effects were reported for this incident.Reviews of the complaint history, device history record (dhr), instructions for use (ifu), and quality control for the device were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify any potential non-conformances prior to distribution.A review of the dhr for the reported complaint device lot and related subassembly lots revealed no recorded non-conformances.A complaint history search did not identify any other events associated with the reported device lot.Based on the available information, cook has concluded that the device was manufactured to specification and that there is no evidence suggesting nonconforming product exists either in house or in the field.Cook also reviewed product labeling.The ifu [t_ce_imwce_rev6] packaged with the device does not have wording about this specific failure.Based on the available information, no product returned, and the results of the investigation, the cause of this event can most likely be traced to an adverse event related to patient condition.The customer informed cook that they are allergic to some metal elements.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the risk assessment no further action is required.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: MREYE EMBOLIZATION COIL
• Common Device Name: KRD DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 18987794
• Report Number: 1820334-2024-00427
• Device Sequence Number: 20928068
• Product Code: KRD
• UDI-Device Identifier: 00827002200555
• UDI-Public: (01)00827002200555(17)280306(10)15256356
• Combination Product (Y/N): N
• PMA/510(K) Number: K150931
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2024

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 Model Number: N/A
• Device Catalogue Number: IMWCE-35-15-15
• Device Lot Number: 15256356
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/19/2024
• Supplement Date Received by Manufacturer: 04/23/2024
• Initial Report FDA Received Date: 03/27/2024
• Supplement Report FDA Received Date: 05/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/06/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male