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

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.
Event or Problem Description
Customer reported that a patient was undergoing an embolization of the internal iliac (hypogastric) artery with a retracta detachable embolization coil prior to repair of an abdominal aortic aneurysm (aaa).The physician reported that the coil broke "a few centimeters" proximal to the attachment zone.The distal end of the broken wire with attached coil remained as deployed in-situ within the hypogastric artery.The physician deployed the retracta detachable embolization coil through a 6fr balkin sheath without the use of a catheter.The physician was successful in occluding / embolizing the entire hypogastric artery and proceeded to cover it with the intended gore endovascular aaa limb.The procedure was completed uneventfully.There were no reported adverse patient consequences.The device is not available for evaluation.
Additional Manufacturer Narrative
Investigation summary: a review of complaint history, device history record, instructions for use (ifu), documentation, manufacturing instructions, specification and quality control data was conducted during the investigation.The complaint device was not returned; therefore, device failure analysis and physical examination of the device used in this case could not be performed.A review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.A review of the work order reveals that there were no nonconformances in this lot or for the subassembly lot, sa7127097, for the delivery wire.A complaint history search reveals that this is the only complaint associated with this lot number.The physician deviated slightly from the instructions for use (ifu).Based on cook's clinical assessment and the customer's reported deviation from the ifu, it is likely that user technique contributed at least partly to the reported mode of failure.User technique will therefore be trended as a possible root cause for the reported failure.We will notify the appropriate personnel and continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.

• 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: 6547515
• Report Number: 1820334-2017-00966
• Device Sequence Number: 16359949
• Product Code: KRD
• UDI-Device Identifier: 10827002342047
• UDI-Public: (01)10827002342047(17)210819(10)7148367
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K123712
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2017

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-35-14-20
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/07/2017
• Supplement Date Received by Manufacturer: 10/03/2017
• Initial Report FDA Received Date: 05/05/2017
• Supplement Report FDA Received Date: 10/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1