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

Catalog Number 640CX2535

Device Problem Delivery System Failure (2905)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/25/2015

Event Type  malfunction  

Event Description

During coil embolization of an unruptured internal carotid artery aneurysm, after re-sheathing the orbit galaxy (640cx2535/17142147), the physician tried to push the embolic coil out, without applying excessive force, to soak it with saline solution.However, the delivery tube was severed from the proximal end.Another coil was inserted to continue the procedure.The procedure was completed without further issues or delay.There were no patient injury/complications.There was no malfunction of the device when it was in the patient.The complaint product was new and stored per labeling instructions.The procedure was conducted in accordance with the instructions for use (ifu) and the constant flush had been maintained at all times.No visible damage was noted on the product prior to the event.The complaint product was discarded.No further information was available.

Manufacturer Narrative

Information regarding patient age or weight were not available.Complaint conclusion: the device was discarded and not available for analysis.Review of dhr for lot 17142147 concluded there were no issues noted that were considered potentially related to the reported complaint.The delivery tube severe could not be confirmed without product return for analysis, and it is not possible to determine the root cause of the event; however, procedural/handling factors may have contributed to the event.There was no evidence to suggest the event was related to a manufacturing issue, and all devices are inspected prior to leaving the manufacturing facility.Therefore, no corrective actions will be taken at this time.This is an initial/final mdr.

• 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: kimberly soter ; circuito interior norte #1820; juarez chihuahua 32580 ; MX 32580 ; 5088288310
• MDR Report Key: 4974689
• MDR Text Key: 19601718
• Report Number: 3008264254-2015-00055
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 07/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2016
• Device Catalogue Number: 640CX2535
• Device Lot Number: 17142147
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/18/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: EXCELSIOR SL-10 (STRYKER)