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

Catalog Number 640CF2505

Device Problem Positioning Failure (1158)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/24/2017

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: a guide wire (gt, terumo), a micro catheter (marvel,tokai medical products), a y connector (okay, goodman) and syringe were also used for this procedure.The customer name could not be provided.Conclusion: the device was not returned for analysis.A review of the manufacturing documentation associated with this lot 17498372 presented no issues during the manufacturing or inspection process that can be related to the reported complaint.The failure to detach the coil could not be confirmed without product return for analysis.The root cause of the event could not be determined based on the information provided.There is no current safety signal identified related to the reported event based on review of complaint history for the device.Since there was no evidence to suggest 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, during coil embolization of a bleeding abdominal artery aneurysm, an orbit galaxy coil (640cf2505/ 17498372) could not be detached.After five coils were used, the orbit galaxy was used, but it could not be detached.The physician tried to detach the coil several times but he could not.The coil was replaced with another one.After that, the procedure was completed with using two additional coils.The unspecified syringe had been filled with saline from a dedicated source of saline and had successfully deployed other coils.The coil delivery system had been prepped without any difficulty.The procedure was successfully completed without further issues or delay.There was also no patient injury / complication reported.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 time through the microcatheter.No visible defect/damage was noted on the products prior to the event.No unintended detachment was observed in the vessel or in the microcatheter.The product was not available for the investigation.No further information was available.

• 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: 6794295
• MDR Text Key: 82781061
• Report Number: 3008264254-2017-00114
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 10886704068181
• UDI-Public: (01)10886704068181(17)180430(10)17498372
• 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
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 07/24/2017

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: 04/30/2018
• Device Catalogue Number: 640CF2505
• Device Lot Number: 17498372
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/24/2017
• Initial Date FDA Received: 08/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/14/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 72 YR