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

Catalog Number	640CF0510
Medical Device Problem Codes	Device Difficult to Setup or Prepare (1487); Failure to Prime (1492)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/15/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: microcatheter (sl10, stryker/ headway, terumo), yconnector (okay, goodman), dcs syringe.The device has been returned for analysis; however, the analysis has not yet been completed.No additional information could be obtained from the customer.Additional information will be submitted within 30 days of receipt.
Event or Problem Description
As reported by a healthcare professional, during coil embolization of a left middle cerebral artery aneurysm, air was found in the hub of the orbit galaxy complex fill (640cf0510/17430048).The microcatheter had been delivered to the lesion through the guiding catheter, and the complaint coil was prepared in accordance with the ifu.During the preparation, air was found at its hub.The coil was replaced with another coil (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 device was prepped and 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 or after the event.No further information was available.
Additional Manufacturer Narrative
Conclusion: as reported by a healthcare professional, during coil embolization of a left middle cerebral artery aneurysm, air was found in the hub of the orbit galaxy complex fill (640cf0510/17430048).The microcatheter had been delivered to the lesion through the guiding catheter, and the complaint coil was prepared in accordance with the ifu.During the preparation, air was found at its hub.The coil was replaced with another coil (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 device was prepped and 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 or after the event.A non-sterile orbit galaxy tdl cmplx fill coil 5x10 was received coiled inside of a plastic bag.The hub, the hypo tube and introducer and were inspected and no damages were noted on them.The support coil, gripper and embolic coil were found inside of the introducer.The gripper and embolic coil were inspected under microscope; no damages were noted on the gripper or the embolic coil, and no obstructions or damage was noted on the purge hole.Using a lab sample syringe, the orbit galaxy was purging on the blue zone; (no air the hub was noted) after that the pressure gauge was increased to the green zone and the coil was detached without any difficulty.A review of the manufacturing documentation associated with this lot 17430048 presented no issues during the manufacturing process that can be related to the reported complaint.The air in the hub was not confirmed during the functional test.The exact cause of the reported failure could not be determined.Neither the drh review nor the product analysis suggests that the failure experienced is related to the manufacturing process.No corrective or preventive actions 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: 6013473
• Report Number: 3008264254-2016-00064
• Device Sequence Number: 19181793
• Product Code: HCG
• UDI-Device Identifier: 10886704030294
• UDI-Public: (01)10886704030294(17)180131(10)17430048
• 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): 09/15/2016

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: 01/31/2018
• Device Catalogue Number: 640CF0510
• Device Lot Number: 17430048
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/15/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/10/2016
• Supplement Report FDA Received Date: 10/25/2016
• Patient Sequence Number: 1
• Patient Age: 62 YR