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

Catalog Number 640CF0412

Device Problem Difficult To Position (1467)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/14/2016

Event Type  malfunction  

Manufacturer Narrative

It was reported that the product would be returned for analysis; however, after 3 attempts to secure the device and obtain additional information, the product was not returned, and no additional information could be obtained.(b)(4).Conclusion: the device was not available for analysis.Review of dhr for lot 17357118 concluded there were no issues that were considered potentially related to the reported complaint.The positioning difficulty and unexpected shape of the orbit galaxy tdl could not be confirmed without product return.Based on the minimal information provided, the root cause of the event could not be determined.Handling/procedural factors or aneurysm characteristics may have contributed to the event.Since there was no evidence, the event was related to a manufacturing issue, no corrective actions will be taken at this time.This is an initial/final mdr report.

Event Description

As reported by a healthcare professional, the first loop (tdl part) of an orbit galaxy tdl complex fill (640cf0412/ 17357118) did not bend inside of the aneurysm.The first loop was deployed as straight shape.It was reported that the product would be returned for analysis; however, after 3 attempts to secure the device and obtain additional information, the product was not returned, and no additional information could be obtained.

Manufacturer Narrative

Product returned for analysis o august 26, 2016.Updated conclusion: as reported by a healthcare professional, the first loop (tdl part) of an orbit galaxy tdl complex fill (640cf0412/ 17357118) did not bend inside of the aneurysm.The first loop was deployed as straight shape.It was reported that the product would be returned for analysis.A non-sterile orbit galaxy tdl cmplx fill coil 4x12 was received coiled inside of a plastic bag.The hypotube was inspected and it was found kinked 121.6cm from the proximal end of hub.The introducer was received un-zipping and it was found without damage.The support coil, gripper and embolic coil were received outside of the introducer.No damages were noted on the support coil.The gripper and embolic coil were inspected under vision system; the gripper was found without damage.The shape of the embolic coil was found normal and without damage.A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing process that can be related to the reported complaint.The coil being out of shape was not confirmed since the shape of the embolic coil was found normal.The positioning difficulty could not be evaluated.The cause of the failure experienced by customer could not be conclusively determined; however, the analysis suggests that the failure reported could not be related to the manufacturing process.Additionally inspections are in place that prevents this kind of failure from leaving the facility.Therefore no corrective action 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: 5856350
• MDR Text Key: 51477513
• Report Number: 3008264254-2016-00045
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 07/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2017
• Device Catalogue Number: 640CF0412
• Device Lot Number: 17357118
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/28/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1