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

Catalog Number	640CF0306
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/02/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This initial/final mdr will be the only report submitted for mfr #3008264254-2017-00056.Procode: krd/hcg.(b)(4).Concomitant medical products: prowler select lp/es microcatheter, complex fill 6mm x 20cm.Conclusion: based on the information, the event could not be confirmed.The product was not returned for analysis; however 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 actions will be taken at this time.
Event or Problem Description
It was reported by a healthcare professional that an entire og cmplx fill coil 3x6 (640cf0306/17463106) prematurely detached in a prowler select lp/es microcatheter (606s155x/lot unknown) during a coil embolization procedure of a cerebral aneurysm.The coil had not been advanced out of the tip of the microcatheter at all, therefore everything was removed from the patient.Reportedly, resistance was experienced during advancement of the coil through the mid portion of the microcatheter.There was no damage noted to the coil prior to use and no kinks were noted on the microcatheter.An adequate continuous flush was maintained through the microcatheter.One complex fill 6mm x 20cm (640cf0620) was successfully used with the prowler select lp/es microcatheter prior to the reported event.The patient¿s information and aneurysm characteristics are unknown.There were no patient complications as a result of the reported event and no additional intervention was required.The procedure was delayed less than 30 minutes.The procedure was completed using another microcatheter and coil.The patient¿s status post procedure is unknown.The device is not being returned for evaluation as it was discarded.

• 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: 6594723
• Report Number: 3008264254-2017-00056
• Device Sequence Number: 979744
• Product Code: KRD
• UDI-Device Identifier: 10886704030218
• UDI-Public: (01)10886704030218(17)180331(10)17463106
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K093973
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 05/03/2017

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: 03/31/2018
• Device Catalogue Number: 640CF0306
• Device Lot Number: 17463106
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/03/2017
• Initial Report FDA Received Date: 05/26/2017
• Patient Sequence Number: 1