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

Model Number	N/A
Medical Device Problem Codes	Material Separation (1562); Stretched (1601); Separation Failure (2547)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)
Date of Event	11/01/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
It was reported that the coil was not able to disconnect the delivery wire.In the end of the procedure the user facility managed to get the wire lose, but then the coil was stretched out in the vessel.The user facility tried to push the coil back with the catheter, but then the coil was stuck along the catheter and the user facility could not take the catheter out otherwise the coil would migrated as well.After awhile the physician was able to get the catheter out with the coil still in the vena ovarica.The patient did not require any additional procedures due to this occurrence.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, device history record, manufacturing instructions, instructions for use (ifu), quality control data, visual inspection, and a dimensional verification was conducted during the investigation.The retracta detachable embolization coils includes a coil and detachable coil delivery wire.The delivery wire was returned for evaluation.There were no kinks or bends observed along the length of the delivery wire.The length of the distal coil and diameter of the wire were both measured to be in specification.The outside diameter of the coil was measured to be slightly below specification.A document based investigation evaluation was also performed.Review of device history record shows no nonconforming events which could contribute to this failure mode.There was one additional reported complaints for this lot number.The device is shipped with an instruction for use (ifu) that describes the intended use.Specific items addressed include: under fluoroscopic visualization, slowly advance the delivery wire until the entire length of the coil exits the distal end of the catheter.Ensure that the junction remains positioned just inside the catheter tip.Note: advancing the delivery wire slowly allows the junction to be seen more easily and reduces the risk of damaging it.If the coil position is correct, use the torque device to turn the delivery wire counterclockwise 8-10 times, until coil detachment can be either felt or visualized under fluoroscopy.Note: it is recommended that the junction remain just inside the tip of the catheter.Based on the information provided and results of the investigation, a definitive root cause could not be determined.Per the quality engineering risk assessment no further action is required.Monitoring for similar complaints will continue.

• 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: 6139367
• Report Number: 1820334-2016-01368
• Device Sequence Number: 19101527
• Product Code: KRD
• UDI-Device Identifier: 10827002342016
• UDI-Public: (01)10827002342016(17)210829(10)7155896
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2017

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: MWCER-35-14-14
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/01/2016
• Supplement Date Received by Manufacturer: 07/28/2017
• Initial Report FDA Received Date: 12/01/2016
• Supplement Report FDA Received Date: 08/11/2017
• 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