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

Model Number	N/A
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter ¿ occupation: unknown.Pma/510(k) #: preamendment.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
As reported a foreign matter like hair was found inside the sterile barrier of a nester platinum embolization microcoil package.Product was not used by the facility and will be returned for investigation.Product did not make patient contact.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.
Additional Manufacturer Narrative
D10: product received on: 16apr2019.Investigation/evaluation : a review of the complaint history, device history record, instructions for use (ifu), quality control, and specifications of the device, as well as inspection of unused product, were conducted during the investigation.The visual inspection of the complaint device confirmed the presence of an unknown fiber within the outer packaging.The device is confirmed to be manufactured out of specification.Additionally, a document based investigation evaluation performed for lot 9335410 showed no nonconformances.A software search revealed no other complaints under lot 9335410 at the time of investigation.Nonconforming product is not suspected in house or in the field.Based on the information provided, the examination of returned product and the results of the investigation, failure was concluded to be manufacturing related.The appropriate personnel have been notified.Risk assessment determined that risk controls are in place to mitigate this failure mode and that additional risk reduction activities are not necessary at this time.Per the quality engineering risk assessment no further action is required.Cook will continue to monitor for similar complaints.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: 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: 8479188
• Report Number: 1820334-2019-00829
• Device Sequence Number: 1634572
• Product Code: KRD
• UDI-Device Identifier: 00827002269866
• UDI-Public: (01)00827002269866(17)231204(10)9335410
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/04/2023
• Device Model Number: N/A
• Device Catalogue Number: MWCE-18-14-10-NESTER
• Device Lot Number: 9335410
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2019
• Initial Date Received by Manufacturer: 04/03/2019
• Supplement Date Received by Manufacturer: 05/20/2019
• Initial Report FDA Received Date: 04/03/2019
• Supplement Report FDA Received Date: 05/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1