MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC TRUFILL DCS ORBIT MINI COMPLEX FILL; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	637MF3575
Medical Device Problem Codes	Stretched (1601); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/15/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).It was reported that the device would be returned for analysis; however, the device has not yet been returned.Additional information will be submitted within 30 days of receipt.
Event or Problem Description
As reported by a healthcare professional, during the coil embolization, there was resistance when the orbit mini complex fill coil (637mf3575/ 17271359) was being advanced through the unspecified microcatheter, and the coil stretched.The coil had not exited the microcatheter.They withdrew the entire coil still attached to the delivery system from the microcatheter, and used a new one to complete the procedure.There was no report of patient injury or clinically significant delay in the procedure.A continuous flush had been maintained through the unspecified microcatheter, and there were no kinks in the microcatheter.A new device was used to complete the procedure.It was reported that the device would be returned for analysis.Patient information was not provided.
Additional Manufacturer Narrative
Conclusion: as reported by a healthcare professional, during the coil embolization, there was resistance when the orbit mini complex fill coil (637mf3575/ 17271359) was being advanced through the unspecified microcatheter, and the coil stretched.The coil had not exited the microcatheter.They withdrew the entire coil still attached to the delivery system from the microcatheter, and used a new one to complete the procedure.There was no report of patient injury or clinically significant delay in the procedure.A continuous flush had been maintained through the unspecified microcatheter, and there were no kinks in the microcatheter.A new device was used to complete the procedure.It was reported that the device would be returned for analysis.Patient information was not provided.A non-sterile orbit mini comp fill 3.5x7.5 was received in knot condition; the introducer was found kinked-unzipped, the embolic coil was found kinked /stretched in knot condition with the gripper and the rest of the device.The received device was inspected under microscope and the embolic coil was found kinked /stretched in knot condition with the gripper and the rest of the device.The od from the delivery tube was measured and was found within specification.The functional test could not be performed due to the condition of the received device.A review of the manufacturing documentation associated with this lot 17271359 presented no issues during the manufacturing process that can be related to the reported complaint.The resistance within the microcatheter could not be evaluated since the device was received in a knotted condition.The coil stretch was confirmed during the visual analysis.The knot condition noted on the received device and the damages found on the embolic coil was apparently caused by applying excessive force on the device but it could not be conclusively determined.The knotted condition was most likely related to post-procedure handling since the device was removed intact from the microcatheter.Neither the analysis nor the dhr suggest that the failure reported could be related to the manufacturing process.Additionally inspections are in place that prevents this kind of failure from leaving the facility.Procedural factors or the unspecified microcatheter appear to have contributed to have these damages.No corrective action will be taken at this time.

• Brand Name: TRUFILL DCS ORBIT MINI COMPLEX FILL
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA
• MDR Report Key: 6033421
• Report Number: 3008264254-2016-00067
• Device Sequence Number: 794816
• Product Code: HCG
• UDI-Device Identifier: 10886704029953
• UDI-Public: (01)10886704029953(17)170531(10)17271359
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K053197
• 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): 09/22/2016

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: 05/31/2017
• Device Catalogue Number: 637MF3575
• Device Lot Number: 17271359
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/22/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/17/2016
• Supplement Report FDA Received Date: 11/17/2016
• Patient Sequence Number: 1