MAUDE Adverse Event Report: OG TDL CMPLX FILL COIL 8X24; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	640CF0824
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During the review of the lot 17645079, one (1) unit was rejected due to the defect kinked coil damaged and one (1) for the defect damaged coil.These defects could be related to the reported issue related to the orbit galaxy complex fill coil 8x24.Further review of the device history record (dhr) confirmed that the rejected units were properly segregated and discarded.There were no other issues noted that would be considered as potentially related to the reported complaint.(b)(4).
Event or Problem Description
The healthcare professional reported that during the coil embolization of an aneurysm at the internal carotid-posterior communicating artery on a (b)(6) male patient with heavily tortuous, moderately calcified vessel, the first coil selected was determined to be undersized and was replaced with the orbit galaxy complex fill coil 8x24 (640cf0824) from lot 17645079.A guiding catheter (fubuki, asahi intecc), a microcatheter (headway, terumo), a y-connector (terumo) and a syringe were also used for the procedure.The framing was not successfully completed and the orbit galaxy complex fill coil became unraveled after being placed in and out of the lesion several times.The coil was replaced with the orbit galaxy complex fill (640cf0925) from lot 17562306.The new coil became stuck at the distal portion of the microcatheter and was removed.The coil was removed and the microcatheter was flushed before the coil was reinserted and the same issue was encountered at the same distal position on the microcatheter.The reported event did not result in any patient injury or adverse event.There was no reported complication.The product was new and stored per labeling instructions.The procedure was conducted in accordance with the instruction for use (ifu) with constant flush maintained at all time.There was no visible defect or damage noted on the product prior to the event.There was no unintended detachment observed in the vessel or in the microcatheter.

• Brand Name: OG TDL CMPLX FILL COIL 8X24
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• MDR Report Key: 7213435
• Report Number: 3008264254-2018-00501
• Device Sequence Number: 1223073
• Product Code: KRD
• UDI-Device Identifier: 10886704030386
• UDI-Public: 10886704030386
• Combination Product (Y/N): N
• PMA/510(K) Number: K093973
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 12/28/2017

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 Expiration Date: 01/31/2019
• Device Catalogue Number: 640CF0824
• Device Lot Number: 17645079
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/28/2017
• Initial Report FDA Received Date: 01/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR