MAUDE Adverse Event Report: COOK INC TORNADO PLATINUM EMBOLIZATION MICROCOIL; KRD DEVICE, EMBOLIZATION, VASCULAR

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Date of Event	08/08/2017
Type of Reportable Event	Serious Injury
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
It was reported by the international customer that, during the introduction of a tornado platinum embolization microcoil into the patient, there was a feeling of resistance nearby the area in which the coil was going to be placed.As precaution, the operator removed the device from the patient and examined it.It was noted that the coil was broken into several pieces.There were reportedly no patient adverse effects; although there was an extension of the procedure time as a result, no additional anesthesia was required.All pieces of the coil were reportedly retrieved.The circumstances surrounding the handling and usage of the device are not fully known.The customer has not confirmed whether or not the product will be returning.
Additional Manufacturer Narrative
(b)(4).Pma/ 510(k): preamendment.Investigation - evaluation: a review of the complaint history, drawings, instructions for use (ifu), device history record, manufacturing instructions, quality control, and visual inspection of the returned device was conducted during the investigation.No systemic issues were found related to the reported complaint.One blue microcatheter with clear hub marked 2.7/130 was returned in used condition.There is biomatter present on the distal tip along with white fibers clinging to it, and possibly biomatter inside of the catheter.There is no apparent kinking of the catheter.There is resistance inside the tip of the catheter, approximately 2mm from the tip.A 0.018" wire was inserted into the catheter through the hub but encounters resistance beginning at the strain relief.Manipulation of the wire allowed the wire to pass through the resistance, however the wire became stuck again within the catheter at 9.5 cm from the proximal tip of the hub.Using the stiff end of the wire, it can be advanced farther, but with resistance.With persistence, the wire eventually bypassed or overcame the resistance but later became stuck again (11 cm past the 9.5 cm = 20.5 cm from hub).The wire could not be advanced farther as it felt the end of the wire was butting up against something solid.When viewing with the microscope camera under bright light, the coil was visible within at least the distal portion of the catheter.Biomatter was also visible within the catheter.It did not appear that the coil inside was in multiple pieces, however we could not determine the length of the coil.A document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.The manufacturing documents in place at the time of manufacture were reviewed and it was found that the coil was thoroughly inspected by quality control.No notable gaps in production or processing controls were identified.The ifu provides specific instructions for sizing of the microcatheter and wire guide used to deliver the coil.Specific details for loading.018 inch microcoils into the delivery catheter are also provided.The risk specification for this product includes the failure mode 'wire breaks' and identifies that risk controls are in place to mitigate the risk of this type of failure.Review of the device history record of the finished product, as well as a review of the sub-assembly lots shows no nonconforming events that would contribute to this failure mode.It should also be noted there were no other reported complaints for this lot number.The coil could have become damaged during loading into the microcatheter or during advancement to the distal end of the microcatheter if the size of the wire guide did not follow ifu guidelines or the patient anatomy was difficult to track through.Based on the information provided, examination of the returned product, and the results of our investigation; a definitive root cause could not be determined.Per the quality engineering risk assessment, no further action is required.Appropriate personnel have been notified and monitoring will continue to be performed for similar complaints.

• Brand Name: TORNADO PLATINUM EMBOLIZATION MICROCOIL
• Common Device Name: KRD DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6849626
• Report Number: 1820334-2017-02895
• Device Sequence Number: 1522269
• Product Code: KRD
• UDI-Device Identifier: 00827002082618
• UDI-Public: (01)00827002082618(17)220511(10)7845806
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 01/16/2018

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: MWCE-18S-3/2-TORNADO
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/23/2017
• Supplement Date Received by Manufacturer: 01/09/2018
• Initial Report FDA Received Date: 09/07/2017
• Supplement Report FDA Received Date: 01/16/2018
• 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