MAUDE Adverse Event Report: OG TDL CMPLX FILL COIL 5X10; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	640CF0510
Medical Device Problem Codes	Stretched (1601); Physical Resistance (2578)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	10/30/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Concomitant: a guiding catheter (shuttle sheath, cook inc) and a micro catheter (tactics/headway, terumo) were also used for this procedure.Patient information, except patient age, could not be obtained.Customer information could not be provided.This event met mdr reporting criteria on 12/13/2017 when it was discovered during product analysis that the coil was stretched.Conclusion: a non-sterile orbit galaxy tdl cmplx fill coil 5x10was received coiled inside of a pouch.The delivery tube was inspected and no damages were noted on it.The introducer was received unzipped separated of the unit.The support coil and gripper was found without damages while the embolic coil was found stretched.The gripper and the embolic coil were inspected under microscope; the gripper was found without damages while the embolic coil was found stretched.The functional test could not be performed since the introducer was received separated from the unit.The dhr review of the manufacturing documentation associated with this lot 17604574 presented no issues during the manufacturing or inspection process that can be related to the reported complaint.The coil being impeded in the introducer could not be evaluated since the introducer was received separated from the unit.The stretched condition noted on the embolic coil was apparently caused by applying excessive force on the devices, but it could not be conclusively determined.Neither the analysis nor the dhr suggest that the failure reported could be related to the manufacturing process.Additionally, inspections are in place that prevents this kind of failure from leaving the facility.Handling and procedural factors could be contributed to this condition.There is no current safety signal identified related to the reported event based on review of complaint history for the device.Since there was no evidence to suggest the event was related to a manufacturing issue, no corrective actions will be taken at this time.
Event or Problem Description
As reported by a healthcare professional, during coil embolization of a ruptured anterior communicating artery aneurysm, there was resistance felt in the introducer sheath of an orbit galaxy complex fill (640cf0510, 17604574), and during product analysis, it was found that the coil was stretched.The guiding catheter and 2 microcatheters were used with an initial coil (galaxy 5mmx15cm), but the coil was too long for the lesion.The coil was replaced with the complaint orbit galaxy and it was attempted to be delivered, but there was resistance felt in the introducer sheath.It was difficult to insert the coil.The coil was replaced with another one (same size).The procedure was successfully completed without further issues or delay.There was also no patient injury / complication reported.The complaint product was new and stored per labeling instructions.The procedure was conducted in accordance with the ifu and the constant flush had been maintained at all time.No visible defect/damage was noted on the products prior to the event.No unintended detachment was observed in the vessel or in the microcatheter.No further information was available.
Additional Manufacturer Narrative
Product complaint : (b)(4).This mdr is being submitted to report the name and address of the facility where the event occurred.The name of the customer could not be provided.

• Brand Name: OG TDL CMPLX FILL COIL 5X10
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• MDR Report Key: 7153753
• Report Number: 3008264254-2017-00509
• Device Sequence Number: 19194367
• Product Code: KRD
• UDI-Device Identifier: 10886704030294
• UDI-Public: (01)10886704030294(17)180930(10)17604574
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 12/13/2017

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: 09/30/2018
• Device Model Number: 640CF0510
• Device Catalogue Number: 640CF0510
• Device Lot Number: 17604574
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2017
• Initial Date Received by Manufacturer: 12/13/2017
• Supplement Date Received by Manufacturer: 02/20/2018
• Initial Report FDA Received Date: 12/29/2017
• Supplement Report FDA Received Date: 02/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR