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

Catalog Number	640CF0515
Medical Device Problem Code	Kinked (1339)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/15/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The product will not be returned for analysis; however, a device history record review is currently being conducted and the results are not yet available.No conclusion is made at this time.Additional information will be submitted within 30 days of receipt.
Event or Problem Description
It was reported by a healthcare professional that during the procedure, an orbit galaxy coil (640cf0515/17518425) kinked.The procedure was coil embolization of an aneurysm for dural arteriovenous fistula at the sigmoid.The patient¿s vessel was mildly torturous and not calcified.A contralateral approach was made from right transverse sigmoid and coil embolization was performed.Embolization using coils (competitor's coils and a galaxy 7*21) was performed.After which the og cmplx fill (complaint coil) was used, however it got kinked.It was unknown when the kink occurred.There were no damages noted on the coil prior to use.The procedure was 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 unintended detachment was observed in the vessel or in the microcatheter.The product is not available for investigation.No further information is available.
Additional Manufacturer Narrative
This is final mdr report being submitted for this complaint with associated mfr# 3008264254-2017-00026.The orbit galaxy coil will not be returned, therefore the root cause of the kinked coil cannot be determined.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 action will be taken at this time.

• Brand Name: ORBIT GALAXY DETACHABLE COIL SYSTEM
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA
• MDR Report Key: 6388021
• Report Number: 3008264254-2017-00026
• Device Sequence Number: 18983266
• Product Code: HCG
• UDI-Device Identifier: 10886704030300
• UDI-Public: (01)10886704030300(17)180531(10)17518425
• 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,Followup
• Report Date (Section B): 02/15/2017

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: 05/31/2018
• Device Catalogue Number: 640CF0515
• Device Lot Number: 17518425
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/15/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/08/2017
• Supplement Report FDA Received Date: 04/04/2017
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TARGET XXL, XL COIL , STRYKERGALAXY 7*21 COIL