MAUDE Adverse Event Report: COOK INC NESTER PLATINUM EMBOLIZATION MICROCOIL; KRD DEVICE, EMBOLIZATION, VASCULAR

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Foreign Body Reaction (1868)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.
Event or Problem Description
The reporter stated that a patient underwent a splenic embolization procedure on an unspecified date to control bleeding following an accident.The patient developed a skin rash / allergic reaction and low grade fever a few weeks following the procedure.The patient was prescribed eucerin and hydrocortisone cream for contact dermatitis.The hospital linens were changed to hypoallergenic.The rash and fever continued for three more days spreading to the patient's chest, shoulders and arms.The patient returned to the emergency room and was treated with intravenous prednisone and benadryl and was also given a prescription for the same for several more days.The rash cleared up.The patient then developed hives in random spots and a pimple-like bumpy rash and itching on the hands, wrist, hips, groin, ankle, calves and feet.The patient was seen by an allergist on (b)(6) 2017 and prescribed levocetirizine tablets and permethrin cream; there was no relief from either medication.On (b)(6) 2017 the patient's primary care physician prescribed methylprednisolone tablets which was taken for four days.The patient has shown improvement, however, waiting to see how the patient will react when the medication is done.Patient was scheduled for follow-up with a dermatologist on (b)(6) 2017.The reporter stated that she "will forward any results from that visit to you." a request was made to the reporter for the results of the dermatology follow-up visit.No additional information was received to date.This is one of three reports being filed as three different product lot numbers were implanted.Reference mdr numbers 1820334-2017-00674, 1820334-2017-00828 and 1820334-2017-00829 for all associated reports.The same patient is involved in each report.
Additional Manufacturer Narrative
A review of documentation, device history record review, manufacturing instructions, specification and quality control data was conducted during the investigation.The complaint device was not returned; therefore, device failure analysis and physical examination of the device used in this case could not be performed.A complaint history search revealed this complaint to be the only reported complaint associated to the complaint lot number.A review of the non-conformance data revealed two (2) non-conformances for the complaint lot number.The listed non-conformances were for coil spacing (1 coil, reworked) and foreign matter (1 coil, reworked).The coil spacing non-conformance was not related to the complaint.The foreign matter non-conformance could have related to the complaint, however the contamination was identified and the device was reworked, therefore this particular non-conformance could not have contributed to the event.The device history record was reviewed for the component part (coil) and no non-conformances were noted for lot number involved in this case.The materials that came in direct patient contact used in the mwce-18-14-6-nester coils consist of platinum (majority platinum and small amount of tungsten) and nylon 6,6 synthetic fibers.The raw material (platinum) in the embolization coil is specified to certain purity levels and numerous controls are in place to make certain the material is properly washed and is free of debris throughout the manufacturing process.Validated processes ensure the device is manufactured in a clean environment and that the final device is sterile.Biocompatibility testing was completed on the materials used in the embolization coil according to the governing standards.It is possible that the patient had an allergic reaction to the materials in the embolization coils or the adverse physiological response could be due to postembolization syndrome (pes) or another side effect of the injury/surgery.A review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.Based on the provided information, no product being returned, a definitive root cause cannot be established or reported at this time.We will notify the appropriate personnel and continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.

• Brand Name: NESTER PLATINUM EMBOLIZATION MICROCOIL
• Common Device Name: KRD DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6500643
• Report Number: 1820334-2017-00674
• Device Sequence Number: 802000
• Product Code: KRD
• UDI-Device Identifier: 00827002269897
• UDI-Public: (01)00827002269897(17)210912(10)7218295
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2017

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: MWCE-18-14-6-NESTER
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/20/2017
• Supplement Date Received by Manufacturer: 08/15/2017
• Initial Report FDA Received Date: 04/18/2017
• Supplement Report FDA Received Date: 08/31/2017
• 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: 19 YR