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

Catalog Number	MWCE-35-14-8-NESTER
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Pma/510(k) #: not exempt.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 that during a fistulogram with coiling procedure, a nester platinum embolization coil unraveled inside the catheter.The physician attempted to flush the coil out, but it would not leave the catheter.At that point, the physician pulled the device, installed a new system and completed the procedure successfully.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Event or Problem Description
No new event description information to report at this time.
Additional 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), manufacturing instructions, quality control, specifications, as well as visual inspection of the returned device were conducted during the investigation.One nester coil was returned for evaluation.Upon visual examination, it was noted that the coil was elongated, severely damaged and had excessive biomatter throughout the device.No additional dimensional or functional analysis could be completed on the device due to the severity of the damage.Additionally, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications, as several verifications and quality inspections are put in place to identify these failures before release.The instructions for use (ifu) note that the coils are designed to be delivered to the target vessel using a soft, straight wire guide through a standard angiographic catheter.Nester embolization coils are not recommended for use with polyurethane catheters or catheters with side ports, as the embolus may lodge in the side port or pass inadvertently through it.Use of polyurethane catheters may also result in the lodging of the embolus within the catheter.As a precaution, the user should flush the angiographic catheter with saline before introduction of the embolization coil.A review of the device history record indicated a ¿coil will not roll¿ nonconformance, which was scrapped.It should be noted that no other complaints have been associated with lot number 8865509.Based on the information provided, the examination of the returned product, and the results of our investigation, a definitive cause was unable to be determined.It is possible that using a non-cook catheter and wire guide with the nester could cause a lodging of the coil in the catheter which upon physical removal, could cause elongation but this has not been confirmed.The appropriate personnel have been notified.Per the quality engineering risk assessment no further action is required.We will continue to monitor for similar events.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.

• 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: 7766738
• Report Number: 1820334-2018-02277
• Device Sequence Number: 19329141
• Product Code: KRD
• UDI-Device Identifier: 00827002269958
• UDI-Public: (01)00827002269958(17)230521(10)8865509
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2018

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: 05/21/2023
• Device Catalogue Number: MWCE-35-14-8-NESTER
• Device Lot Number: 8865509
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2018
• Initial Date Received by Manufacturer: 07/20/2018
• Supplement Date Received by Manufacturer: 10/18/2018
• Initial Report FDA Received Date: 08/09/2018
• Supplement Report FDA Received Date: 11/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TERUMO GLIDE ANGLE WIRE, CORDIS BERN CATHETER; TERUMO GLIDE ANGLE WIRE, CORDIS BERN CATHETER
• Patient Age: 69 YR