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

Model Number N/A

Device Problem Delivered as Unsterile Product (1421)

Patient Problem No Patient Involvement (2645)

Event Date 06/18/2018

Event Type  malfunction  

Manufacturer Narrative

Occupation: unknown.Pma/510(k) #: pre-amendment.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

As reported, during inspection of an nester platinum embolization coil, an unidentified particle was observed inside of the primary packaging.The reporter stated the packaging appeared to be sealed with no identified breakage in seal.Product did not make patient contact.

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown or unavailable.Investigation ¿ evaluation.A review of the complaint history, device history record,instructions for use (ifu), , quality control, and specifications of the device were conducted during the investigation.The device was not returned for investigation, but images of the devices were provided by the distribution center.The images confirmed an unknown particle within the package of the device.In response to this incident, cook reviewed the device history record for the complaint device.The dhr for the complaint lot revealed no reported nonconformances.A software search revealed no other complaints have been reported from the complaint device lot.There is no evidence to suggest other nonconforming product is in house or out in the field.The device's design history files were reviewed.The risks associated with these devices are acceptable when weighed against the benefits.It was concluded that the failure mode was manufacturing related.Foreign matter could have contaminated the device and/or components during the manufacturing process, and sealed inside during packaging.Final qc procedures call for visual examination of the packages/trays for cleanliness and overall appearance.The appropriate personnel have been notified.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 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 COIL
• Type of Device: KRD DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8779967
• MDR Text Key: 150693681
• Report Number: 1820334-2019-01666
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 00827002527546
• UDI-Public: (01)00827002527546(17)231029(10)NS9234499
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 08/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/29/2023
• Device Model Number: N/A
• Device Catalogue Number: MWCE-35-14-20-NESTER
• Device Lot Number: NS9234499
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1