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

Catalog Number 640CF0620

Device Problems Positioning Failure (1158); Stretched (1601)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/07/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).It was reported that the device would be returned for analysis; however, the device has not yet been returned.Additional information will be submitted within 30 days of receipt.

Event Description

As reported by a healthcare professional, an orbit galaxy coil (640cf0620/17604577) could not be detached during the procedure.They used another one to complete the procedure.There was no report of patient injury.It was reported that the device would be returned for analysis.

Manufacturer Narrative

Device was returned for analysis on (b)(6) 2017.Conclusion: as reported by a healthcare professional, an orbit galaxy coil (640cf0620/17604577) could not be detached during the procedure and during product analysis, it was found that the coil was stretched.They used another one to complete the procedure.There was no report of patient injury.Multiple attempts to obtain additional information were unsuccessful.A non-sterile orbit galaxy tdl cmplx fill coil 6x20 was received in tangled condition inside of a plastic bag.The hypo tube was inspected and no damages were noted on it.The introducer was found partially zipped and it was found broken.The support coil, the gripper ant the embolic coil were received outside of the introducer.The gripper and the embolic coil were inspected under microscope and the gripper was found without damage with residues of dry blood on it while the embolic coil was found stretched.Using a lab sample syringe, the orbit galaxy was purging on the blue zone; after that the pressure gauge was increased to the green zone and the coil was detached without any difficulty.During the review of the lot 17604577 it was noted that 1 unit was rejected due to the defect oversize proximal bead and it could be related to the reported complaint.However, the dhr review confirmed that the rejected units were properly segregated and discarded.No other issues were noted that were considered potentially related to the reported complaint.The failure to detach the coil was not confirmed since the coil was able to be detached during product analysis.Process and procedural factors appear to have contributed to the damage found on the device.There is no current safety signal identified related to the reported event based on review of complaint history for the device.Since there was no evidence to suggest the event was related to a manufacturing issue, no corrective actions will be taken at this time.

• Brand Name: ORBIT GALAXY DETACHABLE COIL SYSTEM
• Type of Device: NEUROVASCULAR 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: 6908059
• MDR Text Key: 89476092
• Report Number: 3008264254-2017-00132
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 10886704030348
• UDI-Public: (01)10886704030348(17)180930(10)17604577
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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,Followup
• Report Date: 09/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Catalogue Number: 640CF0620
• Device Lot Number: 17604577
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/21/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1