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

Catalog Number 640CF0412

Device Problem Premature Activation (1484)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/10/2014

Event Type  Injury  

Manufacturer Narrative

Complaint conclusion: after successfully placing 2 galaxy coils to the feeder artery from the pulmonary artery during coil embolization of the shunt part of the major aortopulmonary collateral artery, while advancing the orbit galaxy (640cf0412/16044829), the physician could not feel the movement of the embolic coil, and it was discovered that the embolic coil was prematurely detached from the delivery tube.There was no report of resistance prior to the event.The coil had not reached the target aneurysm.The detached coil was recovered by using a snare catheter.The patient¿s vessels were moderately tortuous but not calcified.After the coil was recovered, the physician inspected the target lesion site, which was fully embolized.The physician concluded the procedure without delivering further coils.Due to the event, the procedure was delayed for 60 minutes, however, the delay was not considered to be clinically significant since there was no patient injury/complication.The complaint product was new and stored per labeling instructions.The procedure was conducted in accordance with the instructions for use (ifu) and a constant flush had been maintained at all times.No visible defect/damage was noted on the product prior to or after the event, and there was no report of the embolic coil getting unraveled/stretched due to the event.No further information was available.A non-sterile orbit galaxy tdl complex fill coil 4x12 was received coiled inside of a plastic bag.The hypotube was found without damage.The introducer was found unzipped and no damages were noted on it.The support coil and gripper were found outside of the introducer.The support coil was found without damage while the gripper was found with wave condition.The embolic coil was not returned for evaluation.The gripper was inspected under microscope and it was found with wave condition, as well as no obstructions or damage was noted on the purge hole.Marks that the embolic coil was attached to the gripper can be observed.Review of dhr for lot 16044829 revealed no issues that were considered potentially related to the reported complaint.The premature detachment could not be evaluated since the coil was not returned.The root cause of the detachment could not be determined; however, procedural/handling factors may have contributed to the event.The damages found on the gripper (wave¿s condition) apparently can occur during the handling of the unit when this was return for evaluation due to it was found outside of the introducer.Neither the analysis nor the dhr suggest that the failure reported could be related to the manufacturing process.Additionally, inspections are in place that prevents this type damage from leaving from the manufacturing facility; therefore, no corrective actions will be taken at this time.

Event Description

(ref: (b)(4) premature detachment.After successfully placing 2 galaxy coils to the feeder artery from the pulmonary artery during coil embolization of the shunt part of the major aortopulmonary collateral artery, while advancing the orbit galaxy (640cf0412/16044829), the physician could not feel the movement of the embolic coil, and it was discovered that the embolic coil was prematurely detached from the delivery tube.There was no report of resistance prior to the event.The coil had not reached the target aneurysm.The detached coil was recovered by using a snare catheter.The patient¿s vessels were moderately tortuous but not calcified.After the coil was recovered, the physician inspected the target lesion site, which was fully embolized.Hence the physician concluded the procedure without delivering further coils.Due to the event, the procedure was delayed for 60 minutes, however, the delay was not considered to be clinically significant since there was no patient injury/complication.The complaint product was new and stored per labeling instructions.The procedure was conducted in accordance with the instructions for use (ifu) and a constant flush had been maintained at all times.No visible defect/damage was noted on the product prior to or after the event, and there was not report of the embolic coil getting unraveled/stretched due to the event.The complaint product will be returned for analysis.No further information was available, including information about patient gender, age or weight.

Manufacturer Narrative

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.

• 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: duane durbin ; circuito interior norte #1820; juarez chihuahua 32580 ; MX 32580 ; 5088288310
• MDR Report Key: 4373503
• MDR Text Key: 12880513
• Report Number: 3008264254-2014-20018
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• PMA/PMN Number: K093973
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2015
• Device Catalogue Number: 640CF0412
• Device Lot Number: 16044829
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/10/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: OKAY II (GOODMAN, TYPE UNKNOWN)
• Patient Outcome(s): Required Intervention