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

Catalog Number 640CF0721

Device Problem Premature Activation (1484)

Patient Problem No Code Available (3191)

Event Date 12/05/2014

Event Type  Injury  

Event Description

Although the complaint orbit galaxy (640cf0721/15788954) was inserted into the target lesion site through an excelsior 1018 microcatheter, since it could not be stably placed, the physician conducted the push-pull technique to re-position the embolic coil.However, during the maneuver the coil became uncontrollable.When examined, the coil was prematurely detached.The detached coil was safely removed by a snare catheter.The coil was not unraveled.The procedure was completed without further issues.However, due to the event it was delayed for 180 minutes.Nevertheless, there were no patient injury/complications.The complaint product was 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 defect was noted on the product prior to the events.The complained product has already been disposed, thus unavailable for analysis.No further information is available.The procedure was the coil embolization of the mapca next to the patient¿s ita with a vessel that was heavily tortuous but not calcified.

Manufacturer Narrative

(b)(4).The product will not be returned for analysis, and additional information will be submitted within 30 days of receipt.

Manufacturer Narrative

Although the complaint orbit galaxy (640cf0721/15788954) was inserted into the target lesion site through an excelsior 1018 microcatheter, since it could not be stably placed, the physician conducted the push-pull technique to re-position the embolic coil.However, during the maneuver the coil became uncontrollable.When examined, the coil was prematurely detached.The detached coil was safely removed by a snare catheter.The coil was not unraveled.The procedure was completed without further issues.However, due to the event it was delayed for 180 minutes.Nevertheless, there were no patient injury/complications.The complaint product was 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 defect was noted on the product prior to the events.The complained product has already been disposed, thus unavailable for analysis.No further information is available.The procedure was the coil embolization of the mapca next to the patient¿s ita with a vessel that was heavily tortuous but not calcified.The device was discarded and not available for analysis.A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection process that can be related to the reported complaint.The reported event could not be confirmed, since the product was not returned for analysis.However, the use of this device with non-codman microcatheters is not recommended per labeling guidelines, additionally the label for use provides guidelines for proper removal and positioning of the device.The event could be related to procedural factors.Also, this lot presented no issues during the manufacturing or inspection process that can be related to the reported complaint.Therefore, no corrective actions will be taken at this time.

• 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: 4327654
• MDR Text Key: 5136747
• Report Number: 3008264254-2014-20017
• 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,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2014
• Device Catalogue Number: 640CF0721
• Device Lot Number: 15788954
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/09/2015
• Initial Date FDA Received: 12/12/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/12/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 43 YR