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

Catalog Number 640CX0406

Device Problem Difficult To Position (1467)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/14/2014

Event Type  malfunction  

Event Description

The procedure was coil embolisation of basilar tip artery aneurysm that was not calcified and mildly tortuous.Access was obtained from right femoral artery.During the procedure, while the physician was placing an orbit galaxy (640cx0406/15727732) into the target aneurysm, it protruded out of the aneurysm.And so, the physician wanted to re-sheath it.However, when he slid the zipper of the coil introducer proximally along the delivery tube, it got stuck in the middle of the introducer tube.Therefore the entire orbit galaxy was safely removed from the patient and was replaced for a new product of different lot (640cx0406, lot unknown), which made it all the way through the same microcatheter (excelsior sl10/stryker, type unknown).Afterwards, the procedure was successfully completed without any further issues.No patient injury/complications were reported.The complaint product was new and was stored per labeling instructions.The procedure was conducted in accordance with the ifu and the constant flush had been maintained at all times.Prior to use, no defect (kink, bends etc) was noted on the product by visual inspection.Also no damages were reported on the device after the event.There was no unintended detachment observed in the aneurysm or in the microcatheter.It is unknown if the microcatheter was re-shaped or not.The complaint product is going to be returned for evaluation.No additional information is available.

Manufacturer Narrative

The product will be returned for analysis, however it has not been received.Additional information will be submitted within 30 days of receipt.Concomitant medical products and therapy dates: new coil (640cx0406, lot unknown), microcatheter (excelsior sl10/stryker, type unknown).

Manufacturer Narrative

During a basilar tip aneurysm coil embolization procedure, when placing the orbit galaxy (640cx0406/15727732) in the basilar tip aneurysm, it protruded out of the aneurysm.Therefore, it was determined to re-sheath it; however, the zipper of the coil got stuck in the middle of the introducer tube when it was slid proximally along the delivery tube.The coil was safely removed from the patient without any unintended detachment or stretching and replaced with another same size orbit galaxy (lot unknown).The procedure was successfully completed without any further issues.There were no patient injuries or complications reported.The device was new and was stored per labeling instructions.The procedure was conducted in accordance with the ifu and the constant flush had been maintained at all times.Prior to use, no defect (kink, bends etc) was noted on the product by visual inspection.Also no damages were reported on the device after the event.It is unknown if the microcatheter was re-shaped or not.No additional information is available.A non-sterile orbit galaxy tight distal loop complex xtrasoft coil 4 x 6 was received coiled inside of a plastic bag.The hypotube was inspected and no damages were noted on it.The introducer was received partially zipped and it was found elongated.The support coil, gripper and the embolic coil were found inside of the introducer and no damages were noted on them.The introducer, gripper and embolic coil were inspected under microscope; the introducer was found elongated while the gripper and the embolic coil were inspected through of the introducer and they were found without damage.The introducer cannot be re-zipping due to the elongated condition found on the introducer.A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing process that can be related to the reported complaint.Although the reported coil protruding out of the aneurysm during positioning prior to detachment cannot be evaluated due to the nature of the event, there were no damages noted on the returned coil.Factors that can contribute to positioning difficulties include aneurysm characteristics /size, neck size as related to the selected coil size, delivery catheter position, and device manipulation.The reported inability to rezip during re-sheathing was confirmed.With analysis it was due to damages to the introducer which appear to be related to application of excessive force; however a definitive conclusion cannot be made.There is no indication of a relationship to any device abnormalities as packaged/received since these damages would have prevented unsheathing of the device during advancement prior to the coil exiting the delivery catheter.Additionally inspections are in place to prevent this type of failures leaving from the facility.With review of the reported information, the analysis, and device history records there is no indication of any manufacturing issues related to the event, with procedural factors addressed in the labeling appearing to have contributed.Therefore, no corrective actions will be taken.

• Brand Name: XTRASOFT ORBIT GALAXY DETACHABLE COIL
• Type of Device: ARTIFICIAL EMBOLIZATION DEVICE
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): CODMAN AND SHURTLEFF, INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: duane durbin ; miami lakes, FL 33014
• MDR Report Key: 3846372
• MDR Text Key: 4613808
• Report Number: 1226348-2014-30028
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K093973
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/15/2014

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
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2014
• Device Catalogue Number: 640CX0406
• Device Lot Number: 15727732
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/07/2014
• Initial Date FDA Received: 06/03/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/30/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 54 YR