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

Catalog Number	640CX3509
Medical Device Problem Codes	Stretched (1601); Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/22/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history record (dhr) for this device is underway but not yet completed.Once completed, the results will be reported within 30 days.No conclusions are made at this time.
Event or Problem Description
The contact from the facility reported that during coil embolization of an irregular left posterior communicating artery aneurysm, the orbit galaxy coil (640cx3509/17507916), the 4th coil in the procedure, stretched when adjusting.The surgeon detached the coil.A part of the coil remained in the parent artery.The surgeon deployed a stent to attach the coil to the artery.The procedure was completed.There was no report on the patient injury.The device is implanted and not available for return.An adequate continuous flush was maintained through the microcatheter at all times.There was no resistance between the guidewire and microcatheter when accessing the target site.There was no resistance at any time during advancement of the coil through the microcatheter.Three other coils went through the same microcatheter without resistance.There were no kinks in the microcatheter that could have contributed to the event.There was no resistance when the coil was advanced or repositioned.It is uncertain whether entanglement with previous coils may have contributed to the event.
Additional Manufacturer Narrative
A non-sterile og cmplx xtrasoft coil 3.5x9 was received coiled inside of a plastic bag.The hypotube was inspected and no damages were noted on it.The introducer was found partially zipped.The support coil was found without damage.The gripper was found outside of the introducer while the embolic coil was not returned for evaluation.The gripper was inspected under microscope and no damages were noted on it.A review of the manufacturing documentation associated with this lot 17507916 presented no issues during the manufacturing process that can be related to the reported complaint.The failures reported by the customer that the coil prematurely detachment during placement and protruded into parent vessel could not be evaluated.The failures reported by the customer as that the coil protruded into the parent vessel and stretched could not be evaluated because the embolic coil was not returned for evaluation.Neither the analysis nor the dhr suggest that the failure reported could be related to the manufacturing process.Procedural factors and handling process may contribute to the failure as reported.No corrective action will be taken at this time.

• 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: 6274800
• Report Number: 3008264254-2017-00009
• Device Sequence Number: 971123
• Product Code: KRD
• UDI-Device Identifier: 10886704030690
• UDI-Public: (01)10886704030690(17)180531(10)17507916
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K093973
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2018
• Device Catalogue Number: 640CX3509
• Device Lot Number: 17507916
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/29/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/24/2017
• Supplement Report FDA Received Date: 02/08/2017
• Patient Sequence Number: 1
• Patient Age: 78 YR