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

Catalog Number	640CF0410
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/07/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).It is anticipated that the device will be returned for analysis; however, the device has not yet been returned.Additional information will be submitted within 30 days of receipt.
Event or Problem Description
As reported by a healthcare professional, during a procedure, the orbit galaxy coil (640cf0410/ 175410090) stretched.The physician removed the coil safely and used another same size coil, and the procedure was successfully completed.There were no potential adverse events.It was reported that the device would be returned for analysis.
Additional Manufacturer Narrative
The device was returned for analysis on 1/5/2017.Conclusion: as reported by a healthcare professional, during a procedure, the orbit galaxy coil (640cf0410/ 175410090) stretched.The physician removed the coil safely and used another same size coil, and the procedure was successfully completed.There were no potential adverse events.Three attempts were made to obtain additional information; however, no additional information was provided.A non-sterile og tdl cmplx fill coil 4x10 was received coiled inside of a plastic bag.The hypotube was inspected and it was found kinked at 28.5, 40.5 and 41.5 cm from the proximal end of hub.The introducer was received zipping and it was found without damage.The support coil, gripper and embolic coil were received inside introducer.The support coil was inspected and it was found without any damage.The gripper and embolic coil were inspected under vision system, and the gripper was found without damages while the embolic coil was found stretched and kinked.The suture of the embolic coil was found broken.The review of lot 17541009 one rejected unit for coil stretched that may be related to the reported complaint; however, the dhr review confirmed that the rejected units were properly segregated and discarded.Inspection is in place that prevents these kinds of damages leaving from the facility.There were no other issues noted that were considered potentially related to the reported complaint.The coil stretch was confirmed.The condition found on the embolic coil was apparently caused by applying excessive force on the device, 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 and procedural factors appear to have contributed to this failure.Additionally inspections are in place that prevents this kind of failure from leaving the manufacturing facility.Handling and procedural factors could be contributed to this condition.Therefore no corrective action will be taken at this time.

• 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: 6215864
• Report Number: 3008264254-2016-00097
• Device Sequence Number: 11030362
• Product Code: HCG
• UDI-Device Identifier: 10886704030263
• UDI-Public: (01)10886704030263(17)180630(10)17541009
• 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: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2016

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: 06/30/2018
• Device Catalogue Number: 640CF0410
• Device Lot Number: 17541009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/07/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/30/2016
• Supplement Report FDA Received Date: 01/25/2017
• Patient Sequence Number: 1