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

Catalog Number	640CX0202
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/21/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is initial mdr report being submitted for this complaint with associated mfr# 3008264254-2017-00004.Additional procode: krd.(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.No conclusions are made at this time.
Event or Problem Description
As reported by a health care professional, during coil embolization an og complex xtrasoft coil 2x2 could not be detached.Pre-deployment electrical check was performed and the system ready light illuminated.During the detachment cycle the light did not illuminate and the audible signal did not beep.All connections appeared to fit properly without application of excessive force.The coil was withdrawn and a new coil was used to complete the procedure.The same connecting cable and dcb used successfully with subsequent coils.The complaint coil was still attached to the delivery system when removed from the patient and no stretching of the coil was noted.There was no report on the patient injury and patient outcome was reported to be fine.There were no intra or post procedural complications or surgical delays related to device or reported event.It was initially reported that the complaint product is available for return.
Additional Manufacturer Narrative
This is final mdr report being submitted for this complaint with associated mfr# 3008264254-2017-00004.Product returned.A non-sterile orbit galaxy cmplx xtrasoft coil 2x2 was received in a tangled condition inside a plastic bag.The hypo tube was found broken at 68cm from the proximal end of the hub and several kinks were noted on it.The introducer was found partially zipped and it was observed that the introducer had a wave condition on it.The support coil was found kinked in spiral condition.The gripper and the embolic coil were found inside of the introducer.The hypotube was inspected under the microscope and the edge of the broken section show evidence that it was kinked before it was broken.The gripper and the embolic coil were inspected too under microscope and the gripper was found without damage while the embolic coil was found stretched.The functional test cannot be performed as the hypotube was found to be broken.A review of the manufacturing documentation associated with this lot 17256209 presented no issues during the manufacturing or inspection process that can be related to the reported complaint.The reported event of failure to detach an orbit galaxy coil could not be evaluated as the hypotube was found broken.The broken condition noted on the hypotube and the damages noted on the device were apparently caused by excessive force being applied on the device but it could not be conclusively determined.However this defect could not be related to the manufacturing process; procedural factors appear to have contributed to this damage.Neither the analysis nor the dhr suggests that the failure reported could be related to the manufacturing process.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: 6255600
• Report Number: 3008264254-2017-00004
• Device Sequence Number: 970915
• Product Code: HCG
• UDI-Device Identifier: 10886704030546
• UDI-Public: (01)10886704030546(17)170430(10)17256209
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 12/27/2016

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: 04/30/2017
• Device Catalogue Number: 640CX0202
• Device Lot Number: 17256209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/27/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/17/2017
• Supplement Report FDA Received Date: 02/08/2017
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ENPOWER (LOT UNKNOWN)