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

Catalog Number	640CF0510
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/09/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This initial mdr is the only report being submitted for mfr report #3008264254-2017-00059.Product code: krd/hcg.(b)(4).The product is expected to be returned for analysis, however it has not been received.Additional information will be submitted within 30 days of receipt.
Event or Problem Description
It was reported by a healthcare professional that a fracture at the proximal hub of an og tdl cmplx fill coil (640cf0510/17535711) was found during preparation and the distal tip of an envoy guiding catheter (67125805d/lot unknown) was kinked upon opening the box.The physician used another of the same size products and completed the procedure successfully.
Additional Manufacturer Narrative
This final mdr will be the only report submitted for mfr #3008264254-2017-00059.A non-sterile orbit galaxy tdl cmplx fill coil 5x10 was received inside of a plastic bag.The hub was inspected and no damages were noted on it.The hypo tube was found broken at 7cm from the proximal end of hub.The introducer was found zipped without damage.The support coil, gripper and the embolic coil was received inside of the introducer.The hypo tube was inspected under microscope; the edges of the broken section of the hypo tube show evidence that appear that it was kinked before it was broken.The gripper and embolic coil were inspected under a microscope and no damages were noted on them.The failure reported by the customer as ¿luer hub - cracked-during prep¿ was not confirmed.The failure experienced by the customer appears was due to the broken section found on the hypo tube.The broken condition was apparently caused by applying excessive force on the device but it could not be conclusively determined.Procedural factors appear to have contributed to have this damage.A review of the manufacturing documentation associated with this lot 17535711 presented no issues during the manufacturing process that can be related to the reported complaint.Neither the analysis, nor the dhr, suggest that the reported failure could be related to the manufacturing process.Additionally, inspections are in place that prevent this kind of failure from leaving the facility.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: 6604556
• Report Number: 3008264254-2017-00059
• Device Sequence Number: 13604710
• Product Code: KRD
• UDI-Device Identifier: 10886704030294
• UDI-Public: (01)10886704030294(17)180630(10)17535711
• Combination Product (Y/N): N
• Initial Reporter Country: KN
• 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,Followup,Followup
• Report Date (Section B): 05/09/2017

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: 06/30/2018
• Device Catalogue Number: 640CF0510
• Device Lot Number: 17535711
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/09/2017
• Supplement Date Received by Manufacturer: Not provided; Not provided; 06/12/2017
• Initial Report FDA Received Date: 06/01/2017
• Supplement Report FDA Received Date: 06/21/2017; 06/22/2017; 07/05/2017
• Patient Sequence Number: 1