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

Catalog Number	640CX3505
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Procode: krd/hcg.(b)(6).Conclusion: a review of the manufacturing documentation associated with this lot 17318976 presented no issues during the manufacturing or inspection process that can be related to the reported complaint.The positioning and resheathing issues could not be confirmed without product return for analysis.The root cause of the event could not be determined; however, procedural/handling factors may have contributed to the failures.There is no current safety signal identified related to the reported events based on reviews of complaint histories for the devices.Since there was no evidence to suggest the event was related to a manufacturing issue, no corrective actions will be taken at this time.
Event or Problem Description
As reported by a healthcare professional, during coil embolization of a ruptured ic-pc aneurysm, an orbit galaxy ((b)(4)) was difficult to position and kicked back and could not be re-sheathed because the zipper became stuck, and orbit galaxy ((b)(4)) was out from the lesion, but did not protrude into the parent vessel and could not be re-sheathed because the zipper became stuck.It was not necessary to remove the microcatheter due to the events.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 ifu and the constant flush had been maintained at all time.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 vessel was not tortuous or calcified.An sl 10 microcatheter was used for the procedure.The products are not available for investigation.No further information was available.

• Brand Name: XTRASOFT ORBIT GALAXY DETACHABLE COIL
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA
• MDR Report Key: 6809715
• Report Number: 3008264254-2017-00116
• Device Sequence Number: 1760498
• Product Code: HCG
• UDI-Device Identifier: 10886704030683
• UDI-Public: (01)10886704030683(17)170731(10)17318976
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K093973
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 07/27/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2017
• Device Catalogue Number: 640CX3505
• Device Lot Number: 17318976
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2017
• Initial Report FDA Received Date: 08/22/2017
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CHIKAI, ASAHI GW, SL10 MICROCATH.