MAUDE Adverse Event Report: OG TDL CMPLX FILL COIL 5X15; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	640CF0515
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/09/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The patient¿s age at the time of event is not known.The patient¿s gender is not known.The patient's weight is not known.A review of the manufacturing documentation associated with lot 1765445 presented no issues during the manufacturing or inspection process that can be related to the reported complaint.The device has not been returned.If the device returns, a device investigation will be performed.Additional information will be submitted within 30 days of receipt.(b)(4).
Event or Problem Description
The healthcare professional reported that during the procedure, the orbit galaxy complex fill coil (640cf0515 / 17625445) became stretched.The coil was withdrawn and another coil was used to complete the procedure.There was no report of patient injury.
Additional Manufacturer Narrative
The healthcare professional reported that during the procedure, the orbit galaxy complex fill coil (640cf0515 / 17625445) became stretched.The coil was withdrawn and another coil was used to complete the procedure.There was no report of patient injury.The non-sterile orbit galaxy tdl complex fill coil 5x15 was received coiled inside of a pouch.The hypotube was inspected and no damages were noted on it.The introducer was found unzipped.The support coil, the gripper and the embolic coil were found outside of the introducer.The gripper and embolic coil were inspected under microscope; no damages were noted on the gripper.The embolic coil was found stretched and the suture was found broken.The edges of the broken section of the suture show evidence that appear that it was elongated before it was broken.A review of the manufacturing documentation associated with lot 1765445 presented no issues during the manufacturing or inspection process that can be related to the reported complaint.The customer reported failure of the coil being unraveled / stretched during placement was confirmed.The cause of the coil stretched condition was mostly due to excessive force applied on the device.Procedural related factors and handling process appeared to have contributed to the reported failure.The exact cause of the failure cannot be conclusively determined.The reported failure could not be related to the manufacturing process as there are additional inspections in placed to prevent these kinds of failure from leaving the facility.There is no current safety signal identified related to the reported event based on review of complaint history for the device.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no corrective actions will be taken at this time.

• Brand Name: OG TDL CMPLX FILL COIL 5X15
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• MDR Report Key: 7088067
• Report Number: 3008264254-2017-00503
• Device Sequence Number: 1310445
• Product Code: KRD
• UDI-Device Identifier: 10886704030300
• UDI-Public: (01)10886704030300(11)161202(17)181031(10)17625445
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2017

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: 10/31/2018
• Device Model Number: 640CF0515
• Device Catalogue Number: 640CF0515
• Device Lot Number: 17625445
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2018
• Initial Date Received by Manufacturer: 11/10/2017
• Supplement Date Received by Manufacturer: 11/10/2017
• Initial Report FDA Received Date: 12/06/2017
• Supplement Report FDA Received Date: 01/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1