MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC ORBIT GALAXY DETACHABLE COIL SYSTEM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	640CF0615
Medical Device Problem Codes	Kinked (1339); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/19/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Add'l pro code: krd/hcg.(b)(4).Conclusion: the device was not returned for analysis.Review of dhr for lot 17449388 concluded there were 2 rejected units due to kinked coil that may be related to the reported complaint.However, the dhr review confirmed that the rejected units were properly segregated and discarded.Controls are in place to detect such nonconformities.The resistance and coil kink could not be confirmed without product return for analysis.The root cause of the event could not be determined; however, the concomitant microcatheter may have contributed to the event.Since there was no evidence to suggest the event was related to a manufacturing issue, no corrective actions will be taken at this time.This is an initial/final mdr report.
Event or Problem Description
As reported by a healthcare professional, during coil embolization of a subarachnoid hemorrhage of the internal carotid-posterior cerebral artery aneurysm, there was resistance between an orbit galaxy (640cf0615/ 17449388) and an sl 10 microcatheter, and the coil became kinked.The orbit galaxy was the first coil used for the procedure.The coil was replaced with another same size galaxy coil and the procedure was completed successfully 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 through the microcatheter at all time.No visible defect/damage was noted on the products prior to or after the event.No unintended detachment was observed in the vessel or in the microcatheter.The product was not available for investigation.No further information was available.

• Brand Name: ORBIT GALAXY DETACHABLE COIL SYSTEM
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA
• MDR Report Key: 6314010
• Report Number: 3008264254-2017-00016
• Device Sequence Number: 1563458
• Product Code: HCG
• UDI-Device Identifier: 10886704030331
• UDI-Public: (01)10886704030331(17)180228(10)17449388
• 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
• Report Date (Section B): 01/19/2017

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: 02/28/2018
• Device Catalogue Number: 640CF0615
• Device Lot Number: 17449388
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2017
• Initial Report FDA Received Date: 02/09/2017
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MICROCATHETER (SL10, STRYKER)
• Patient Age: 76 YR