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

Model Number	N/A
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: boston scientific, benson 150cm wire, (b)(4), terumo glidecath, cg417, 4fr, 120cm, 0.38.Occupation: lead tech/cvt.Pma/510(k) #: pre-amendment.(b)(4).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
It was reported a nester platinum embolization coil used in a (b)(6) female for ovarian vein embolization.Report states as the last coil was deployed, coil would advance further and was noted to have unraveled (elongated) in the renal vein.The coil was retrieved successfully in a second procedure.No other adverse effects were reported for this incident.
Additional Manufacturer Narrative
Correction: description of event: it should be noted the initial procedure was completed successfully, but two additional procedures were required to retrieve the device.Investigation:evaluation: a review of the complaint history, device history record, drawing, instructions for use (ifu), manufacturing instructions, quality control, and specifications of the device, were conducted during the investigation.The device was not returned for investigation.However, cook received another complaint for the same device for a similar failure mode under pr234521 (medwatch report#: 1820334-2018-02277).Physical examination of this returned device showed the coil was elongated, damaged, and contained excessive biomatter.Based on the condition of the device, no dimensional measurements could be performed, but there was no evidence to suggest the device was not manufactured to specification.The investigation concluded that the cause of the failure could not be determined, but that it was possible that the coil became stuck inside the catheter and could not be deployed, causing unraveling upon removal.Due to the similarities between the referenced complaint and the current complaint, it is possible that the two events have a similar cause.With the known information, there is no evidence to suggest the complaint device was manufactured out of specification.Additionally, a document based investigation evaluation was performed.No nonconformances were reported for lot: 9419299.No nonconformances were reported for the coil subassembly lots.A software search revealed no other complaints have been reported for the complaint lot.As there are no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints that have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.Based on the information provided, no returned product and the results of the investigation, a definitive cause was established as "could not be traced to device." 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.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• Brand Name: NESTER PLATINUM EMBOLIZATION COIL
• Common Device Name: KRD DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8520184
• Report Number: 1820334-2019-00832
• Device Sequence Number: 1846464
• Product Code: KRD
• UDI-Device Identifier: 00827002269958
• UDI-Public: (01)00827002269958(17)240116(10)9419299
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2019

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?: Yes
• Operator of Device: No Information
• Device Expiration Date: 01/16/2024
• Device Model Number: N/A
• Device Catalogue Number: MWCE-35-14-8-NESTER
• Device Lot Number: 9419299
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/02/2019
• Supplement Date Received by Manufacturer: 05/08/2019
• Initial Report FDA Received Date: 04/16/2019
• Supplement Report FDA Received Date: 05/08/2019
• 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: 31 YR
• Patient Weight: 57