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

Catalog Number 640CX0202

Device Problem Positioning Failure (1158)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/10/2014

Event Type  malfunction  

Event Description

The orbit galaxy coil (640cx0202/17065850) would not detach after multiple attempts pressurizing the syringe to alternative detachment zone (zone 4).

Manufacturer Narrative

Review of dhr for lot 17065850 revealed no anomalies that could be related to the reported issue.The product is expected for analysis however is not yet returned.Additional information will be provided within 30 days of receipt.No conclusion is made at this time.Also, the manufacture and expiration dates are being researched and will be provided with the supplemental report.

Manufacturer Narrative

The device was not returned.Based on the information, the event could not be confirmed.The product was not returned for analysis; however 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.Therefore, no corrective actions will be taken at this time.

• Brand Name: XTRASOFT ORBIT GALAXY DETACHABLE COIL
• 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: 4301069
• MDR Text Key: 5084794
• Report Number: 3008264254-2014-20015
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093973
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2016
• Device Catalogue Number: 640CX0202
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/31/2014
• Initial Date FDA Received: 12/05/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/31/2014
• Date Device Manufactured: 07/29/2014
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SYRINGE (DETAILS UNKNOWN)