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

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Date of Event	03/02/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pt identifier) information not provided by reporter.Age at time of event) information not provided by reporter.Weight) information not provided by reporter.(b)(4).The event is currently under investigation.
Event or Problem Description
An embolization procedure was being performed on the male patient.The guide catheter was placed and the coil was placed through the glide catheter when the tip of the coil broke off, during deployment of the coil.The glide catheter was about to be used to remove the tip of the coil from the right atrium.The remaining coil stayed in the patient as intended without incident.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
(b)(4).Investigation - evaluation: a review of the complaint history, dimensional verification, device history record, instructions for use (ifu), manufacturing instructions, specifications, quality control and visual inspection of the returned device was conducted during the investigation.The customer returned one separated segment of an imwce embolization coil.The ~2.4 mm separated tip of the coil was examined.The customer statement indicates that the segment is the top of the coil; however, tip junction was not present on the returned piece.A document based investigation evaluation was also performed.There is no evidence to suggest the product was not made to specifications.Review of device history record shows no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Based on the information provided, examination of the returned device and the results of our investigation, a definitive root cause could not be determined.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.

• Brand Name: MREYE EMBOLIZATION COIL
• Common Device Name: KRD DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 5664277
• Report Number: 1820334-2016-00352
• Device Sequence Number: 23628
• Product Code: KRD
• UDI-Device Identifier: 00827002424081
• UDI-Public: (01)00827002424081(17)191120(10)5422782
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K052834
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2016

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: IMWCE-35-3-3
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/02/2016
• Device Age: 18 MO
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/05/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/18/2016
• Supplement Report FDA Received Date: 06/22/2017
• 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