MAUDE Adverse Event Report: COOK INC RETRACTA DETACHABLE EMBOLIZATION COIL; KRD DEVICE, EMBOLIZATION, VASCULAR

Catalog Number UNKNOWN

Device Problem Difficult or Delayed Separation (4044)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

Possible rpn based on measurements of returned device: mwcer-35-7-6.A follow up report will be submitted should additional relevant information become available.

Event Description

It was reported an unknown cook retracta detachable embolization coil was returned to cook.The coil was discovered to be difficult to detach from the delivery wire.Additional information regarding the device identity, event details, and patient outcome has been requested but is currently unknown.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation ¿ evaluation.(b)(6) hospital (united states) returned to cook on (b)(6) 2021 a coil that was difficult to detach from an unknown rpn or lot number.It was noted that the coil was a retracta detachable embolization coil.There was no information provided regarding the incident or on the impact on the patient.Reviews of the complaint history, quality control, and instructions for use (ifu), as well as a visual inspection of the returned device and interview of personnel were conducted during the investigation.One retracta coil was received used.The coil is attached to the delivery wire.An attempt to unscrew the coil off the delivery wire was unsuccessful.Dry biomatter was present.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the dhr could not be performed as the lot number for the complaint device was not provided.Cook could not review the sales history for this customer and was unable to identify the complaint lot.Based on the available information, cook has concluded that there is no evidence suggesting nonconforming product exists either in house or in field.Cook also reviewed product labeling.The ifu packaged with the device contains the following in relation to the reported failure mode: "how supplied.Upon removal from package, inspect the product to ensure no damage has occurred." based on the information provided, inspection of the returned device, and the results of the investigation, the cause of this event is component failure.Cook confirmed that the coil did not fully detach.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the risk assessment no further action is required.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: RETRACTA DETACHABLE EMBOLIZATION COIL
• Type of Device: KRD DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC.; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 11757364
• MDR Text Key: 262011887
• Report Number: 1820334-2021-01266
• Device Sequence Number: 1
• Product Code: KRD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151676
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1