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

Catalog Number	637HF0206
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/09/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was returned for analysis; however, the analysis has not yet been completed.Additional information will be submitted within 30 days of receipt.
Event or Problem Description
As reported by a healthcare professional, during the coil embolization, the orbit helical fill coil (637hf0206/17360454) could not be detached.They withdrew the coil and used a new coil to complete the procedure using the same unspecified syringe.Prior to attempt to detach, it was verified under fluoro that there was no stress against the microcatheter or delivery tube.Neither the coil nor the delivery system appeared damaged during the procedure.There was no report of patient injury.It was reported that the device would be returned for analysis; however, the syringe was discarded.
Additional Manufacturer Narrative
As reported by a healthcare professional, during the coil embolization, the orbit helical fill coil (637hf0206/17360454) could not be detached.They withdrew the coil and used a new coil to complete the procedure using the same unspecified syringe.Prior to attempt to detach, it was verified under fluoro that there was no stress against the microcatheter or delivery tube.Neither the coil nor the delivery system appeared damaged during the procedure.There was no report of patient injury.It was reported that the device would be returned for analysis; however, the syringe was discarded.A non-sterile orbit helical fill 2x6 was received coiled inside of a plastic bag.The hub, the hypo tube and introducer were inspected and no damages were noted.The support coil, gripper and embolic coil were found outside of the introducer.The gripper and embolic coil were inspected under microscope; no damages were noted on the gripper while the embolic coil was found stretched in tangled condition.Using a lab sample syringe, the orbit device was purging on the blue zone.The pressure gauge was increased to the green zone and the embolic coil was detached without any difficulty.A review of the manufacturing documentation associated with this lot 17360454 presented no issues during the manufacturing process that can be related to the reported complaint.The detachment failure was not confirmed during the functional test.The cause of the stretched condition found on the embolic coil was apparently caused by applying excessive force on the device but it could not be conclusively determined.However, this defect could not be related to the manufacturing process and procedural factors appear to have contributed to have this damage.It was reported that the device did not appear damaged during the procedure, and the device was returned entangled; therefore, the coil stretch was related to post-procedure handling.Devices are inspected for this type of damage prior to being released for distribution.Neither the analysis nor the dhr suggest that the failure reported could be related to the manufacturing process therefore, 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: 6607438
• Report Number: 3008264254-2017-00062
• Device Sequence Number: 19152011
• Product Code: HCG
• UDI-Device Identifier: 10886704029670
• UDI-Public: (01)10886704029670(17)171130(10)17360454
• 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): 05/11/2017

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: 11/30/2017
• Device Catalogue Number: 637HF0206
• Device Lot Number: 17360454
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/11/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/02/2017
• Supplement Report FDA Received Date: 06/23/2017
• Patient Sequence Number: 1