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

Catalog Number 640CF0515

Device Problems Positioning Failure (1158); Difficult To Position (1467)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/30/2016

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: headway (terumo), okay (goodman), enpower dcb / cable (lots unknown).(b)(4).Conclusion: the orbit galaxy was not available for analysis.Review of dhr for lot 17298690 concluded there were no issues that were considered potentially related to the reported complaint.The failure to detach could not be confirmed without product return for analysis.The root cause of the event could not be determined; however, procedural/handling factors may have contributed to the event.Based on the information provided, there was no evidence the event was related to a manufacturing issue; therefore, no corrective actions will be taken at this time.This is an initial/final mdr report.

Event Description

As reported by a healthcare professional, during coil embolization to treat anterior communicating artery subarachnoid hemorrhage, when the physician attempted to detach the orbit galaxy (640cf0515/17298690) with the dcs syringe ii (635002/96331262), the embolic coil unexpectedly moved and the gauge of the syringe did not move from the detach zone.The galaxy and the syringe were both replaced with new devices because, even though the physician would have preferred to re-loop the coil inside the aneurysm again, he was apprehensive of premature detachment of the coil.There was no difficulty in removing the coil, and no damage was noted on the coil after removal.This was the first use of the syringe, and it had not previously exceeded the green zone/position 3.Prior to attempting to detach the coil, it was verified under fluoro that there was no stress against the microcatheter or delivery tube.The dcs syringe pressurized as intended.Another galaxy of the same size was then successfully detached in the aneurysm using a new dcs syringe.The procedure was completed without further issues or delay.There were no patient injuries or complications.The complaint products were new and stored per labeling instructions.The procedure was conducted in accordance with the ifu, and the constant flush had been maintained at all times.No visible damages were noted on the products prior to the event.Due to the infection, the complaint products were not returned for analysis.No further information was available.

• Brand Name: ORBIT GALAXY DETACHABLE COIL SYSTEM
• Type of Device: ARTIFICIAL EMBOLIZATION DEVICE
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA
• Manufacturer Contact: karen anigbo ; circuito interior norte #1820; juarez chihuahua 32580 ; MX 32580 ; 5088288374
• MDR Report Key: 5803279
• MDR Text Key: 49971464
• Report Number: 3008264254-2016-00037
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K093973
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 06/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2017
• Device Catalogue Number: 640CF0515
• Device Lot Number: 17298690
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/30/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/28/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 56 YR