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

Catalog Number	640CF0925
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pro code: krd/hcg.The device was returned for analysis; however, the analysis has not yet been completed.Additional information will be submitted within 30 days of receipt.
Event or Problem Description
As reported by a healthcare professional, when the surgeon advanced an orbit galaxy coil (640cf0925/ 17366792) into the unspecified microcatheter, the coil detached from the detach zone.A continuous flush had been maintained through the microcatheter, and the microcatheter did not appear damaged.The surgeon used another coil to successfully complete the procedure.There were no potential adverse events.No additional information could be obtained.It was reported that the device would be returned for analysis.
Additional Manufacturer Narrative
See section f10 for additional device code since the product was returned with hypotube separation.Conclusion: as reported by a healthcare professional, when the surgeon advanced an orbit galaxy coil (640cf0925/ 17366792) into the unspecified microcatheter, the coil detached from the detach zone.A continuous flush had been maintained through the microcatheter, and the microcatheter did not appear damaged.The surgeon used another coil to successfully complete the procedure.There were no potential adverse events.No additional information could be obtained.It was reported that the device would be returned for analysis.A non-sterile orbit galaxy tdl cmplx fill coil 9x25 was received in inside of a plastic bag.The hypo tube was found broken.The introducer, part of the hypo tube and the hub were not returned for evaluation.Just part of the hypo tube, the support coil gripper and the embolic col were received for evaluation.The gripper and embolic coil were inspected under microscope; no damages were noted on the gripper while the embolic coil was found stretched as well as the edge of the broken section of the hypotube show evidence that appear that it was kinked before it was broken.The functional test could not be performed since the hypo tube was found broken.A review of the manufacturing documentation associated with this lot 17366792 presented no issues during the manufacturing process that can be related to the reported complaint.The premature detachment was not confirmed since the embolic coil was received attached to the gripper.The cause of the separated condition was apparently caused by applying excessive force on the device but it could not be conclusively determined; however, this defect could not be related to the manufacturing process and procedural factors appear to have contributed to have this damage.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.Since there was no evidence of a manufacturing issue related to the event, no corrective actions will be taken at this time.

• Brand Name: ORBIT GALAXY DETACHABLE COIL SYSTEM
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): CODMAN SHURTLEFF INC.; 325 paramount dr.; raynham MA
• Manufacturer Contact: karen anigbo ; circuito interior norte 1820; juarez chihuahua 32580 ; MX 32580 ; 5088288374
• MDR Report Key: 6600574
• Report Number: 3008264254-2017-00050
• Device Sequence Number: 11559162
• Product Code: HCG
• UDI-Device Identifier: 10886704030409
• UDI-Public: (01)10886704030409(17)171031(10)17366792
• Combination Product (Y/N): N
• Initial Reporter Country: KN
• PMA/510(K) Number: K093973
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2017

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
• Device Expiration Date: 10/31/2017
• Device Catalogue Number: 640CF0925
• Device Lot Number: 17366792
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/12/2017
• Supplement Date Received by Manufacturer: 04/12/2017
• Initial Report FDA Received Date: 05/31/2017
• Supplement Report FDA Received Date: 05/31/2017
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/18/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK MICROCATHETER.
• Patient Sex: Unknown