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

Model Number	N/A
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/14/2017
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
The international customer reported that the device became unraveled during use.The unraveling reportedly occurred following the delivery of the coil as intended by the operator.No further complications were reported.
Additional Manufacturer Narrative
Investigation - evaluation: a review of device history record, complaint history, manufacturing instructions, quality control documents, instructions for use (ifu) and visual inspections was conducted during on the returned product during the investigation.The device returned was a coil delivery wire in a used, damaged, and elongated condition.The wire was found to be almost entirely unraveled and had separated (both mandril wire and coil) from the proximal end of the device.The separated and coiled section of the delivery wire was also returned with the attachment coil still clearly attached, indicating that the separation occurred at the level of the proximal coil.No embolization coil was present (as it was deployed successfully in the patient).The separation was not related to a solder or weld.The attachment coil did not appear damaged in any way.Relevant measurements were not able to be taken due to the damaged condition of the returned device.A document review confirmed that the delivery wire and coil are inspected for nonconformities and have dimensions and materials specified.The device history record was reviewed and did not reveal any non-conformances for this lot or the component lot.A search of our complaint records for both lot numbers was performed and confirmed this to be the only complaint regarding these lot numbers.The failure mode of the delivery wire separation has been addressed in risk specifications and risk controls are in place to mitigate the risk.The device history record was reviewed and did not reveal any non-conformances for lot number.Additionally, a complaint history search was performed on the complaint lot numbers and it was confirmed to be the only complaint on the lots at this time.The ifu instructs "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.Note: if significant resistance is encountered during coil advancement, do not continue advancing.If there is still significant resistance, withdraw the delivery wire from the catheter and try using a new coil with a shorter length" and "note: it is recommended that the junction remain just inside the tip of the catheter.Note: do not advance the delivery wire after the coil is detached.Gently remove the delivery wire after coil detachment." based on inspection of the returned device showing that the mandril wire and coil were separated whereas the delivery wire attachment coil was intact, it is possible that the coil encountered difficulty detaching due to the separation hindering the ability to adequately rotate the delivery wire.The separation could have been caused by user technique or difficult patient anatomy.It is unclear whether the device separated or unraveled first.It is also possible that over-torqueing of the delivery wire in attempt to detach the coil caused the separation.An additional possible root cause could be user error if the ifu directions were not followed and the junction of the wire was outside of the catheter during deployment, making it difficult to release the coil and causing damage to the delivery wire.A definitive root cause could not be determined.The appropriate personnel have been notified and we will continue to monitor for similar events.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: 6823465
• Report Number: 1820334-2017-02785
• Device Sequence Number: 11030648
• Product Code: KRD
• UDI-Device Identifier: 10827002342009
• UDI-Public: (01)10827002342009(17)220329(10)7732696
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K123712
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• 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-35-14-12
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/14/2017
• Supplement Date Received by Manufacturer: 10/02/2017
• Initial Report FDA Received Date: 08/28/2017
• 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