MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC (MEXICO) OG TDL CMPLX FILL COIL 4X12; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	640CF0412
Medical Device Problem Codes	Difficult To Position (1467); Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A review of the manufacturing documentation associated with lot 17468435 presented no issues during the manufacturing or inspection process that can be related to the reported complaint.Concomitant med products: guiding catheter (4fr sniper high flow ¿ terumo clinical supply), microcatheter (155cm carnelian marvel, tokai medical products), orbit galaxy tdl complex fill 4 x 12 coils (640cf0412 x 5), and orbit galaxy complex fill coil (640cf0308).The initial reporter name, phone and email are not available.Additional information will be submitted within 30 days of receipt.
Event or Problem Description
The healthcare professional reported that during the post-endovascular aneurysm repair (evar) procedure of a type 2 endoleak at the lumbar artery, after five (5) orbit galaxy tdl complex fill coils 4 x 12 (640cf0412) were successfully placed, the 6th coil, another orbit galaxy tdl complex fill 4 x 12 coil (640cf0412 / 17468435) was used; the coil was in and out of the microcatheter (155cm carnelian marvel, tokai medical products), the coil was torn at the middle.The coil portion still attached to the delivery wire was removed.The portion of the coil that remained in the body was placed in the target lesion as is.Another orbit galaxy complex fill coil (640cf0308) was placed and the procedure was successfully completed without further issue or delay.There was no report of patient injury or complication; the complaint product was new and was 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.
Additional Manufacturer Narrative
Product complaint # (b)(4).The healthcare professional reported that during the post-endovascular aneurysm repair (evar) procedure of a type 2 endoleak at the lumbar artery on (b)(6) 2018 (originally, the event date was reported as (b)(6) 2018.This is related to the time zone of the initial reporter), after five (5) orbit galaxy tdl complex fill coils 4 x 12 (640cf0412) were successfully placed, the 6th coil, another orbit galaxy tdl complex fill 4 x 12 coil (640cf0412 / 17468435) was used; the coil was in and out of the microcatheter (155cm carnelian marvel, tokai medical products), the coil was torn at the middle.The coil portion still attached to the delivery wire was removed.It was confirmed that the delivery system was removed with part of the coil still attached.The portion of the coil that remained in the body was placed in the target lesion as is.Another orbit galaxy complex fill coil (640cf0308) was placed and the procedure was successfully completed without further issue or delay.There was no report of patient injury or complication; the complaint product was new and was 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.The device was not available to be returned for analysis.A review of the manufacturing documentation associated with lot 17468435 presented no issues during the manufacturing or inspection process that can be related to the reported complaint.The reported issues of coil positioning difficulty and coil separated in patient could not be confirmed without the device return for analysis.The root cause of the event could not be determined; however, procedural / handling factors may have contributed to the event.Additional information will be submitted within 30 days of receipt.

• Brand Name: OG TDL CMPLX FILL COIL 4X12
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC (MEXICO); circuito interior norte #1820; juarez chihuahua ; MX
• MDR Report Key: 7383911
• Report Number: 3008264254-2018-00517
• Device Sequence Number: 1426595
• Product Code: KRD
• UDI-Device Identifier: 10886704030270
• UDI-Public: (01)10886704030270(11)160413(17)180331(10)17468435
• 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,Followup
• Report Date (Section B): 04/15/2018

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 Expiration Date: 03/31/2018
• Device Model Number: 640CF0412
• Device Catalogue Number: 640CF0412
• Device Lot Number: 17468435
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/15/2018
• Supplement Date Received by Manufacturer: 04/15/2018
• Initial Report FDA Received Date: 03/29/2018
• Supplement Report FDA Received Date: 04/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1