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

Model Number	N/A
Medical Device Problem Code	Difficult or Delayed Positioning (1157)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/12/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event is currently under investigation.
Event or Problem Description
During a varicocele embolization to spermadic vein procedure, the physician was trying to deploy the retracta coil and the thread became entangled with the adjacent nester coil that had already been deployed.This prevented a smooth deployment, it eventually came off after forceful manipulation.The patient did not require any additional procedures nor experience adverse effects due to this occurrence.No part of the device remained inside the patient.No adverse effects to the patient were reported due to this occurrence.
Additional Manufacturer Narrative
(b)(4).Product has been received and the investigation is ongoing.A follow up report will be sent upon completion of the investigation.
Event or Problem Description
During a varicocele embolization to spermadic vein procedure, the physician was trying to deploy the retracta coil and the thread became entangled with the adjacent nester coil that had already been deployed.This prevented a smooth deployment, it eventually came off after forceful manipulation.The patient did not require any additional procedures nor experience adverse effects due to this occurrence.No part of the device remained inside the patient.No adverse effects to the patient were reported due to this occurrence.
Additional Manufacturer Narrative
Investigation ¿ evaluation a review of device history record, drawings, and instructions for use (ifu), visual inspection, quality controls, and manufacturing instructions was conducted on the returned device during the investigation.The delivery wire was returned for investigation and evaluated.The end of the wire is stretched and unraveled.No coil was returned for investigation.There is no evidence to suggest the finished product was not made to specifications.Review of the device history record of the finished product shows no nonconforming events that would contribute to this failure mode.There were no other reported complaints for this lot number.Based on the provided information, a definitive root cause cannot be determined at this time.Per the quality engineering risk assessment, no further action is warranted.Monitoring will continue to be performed for similar complaints.

• Brand Name: RETRACTA DETACHABLE EMBOLIZATION COIL
• Common Device Name: KRD DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 5935406
• Report Number: 1820334-2016-00953
• Device Sequence Number: 18933234
• Product Code: KRD
• UDI-Device Identifier: 10827002341989
• UDI-Public: (01)10827002341989(17)210513(10)6921907
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K123712
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/22/2017

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 Model Number: N/A
• Device Catalogue Number: MWCER-35-14-8
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/13/2016
• Supplement Date Received by Manufacturer: Not provided; 08/04/2017
• Initial Report FDA Received Date: 09/08/2016
• Supplement Report FDA Received Date: 12/07/2016; 08/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1