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

Catalog Number	637HF0208
Medical Device Problem Codes	Difficult To Position (1467); Stretched (1601)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/08/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).The device was returned for analysis; however, the device has not yet been completed.This complaint met mdr reporting criteria on 5 may 2017 when it was reported that the coil was stretched.Additional information will be submitted within 30 days for receipt.
Event or Problem Description
As reported by a healthcare professional, during the coil embolization, the orbit helical fill (637hf0208/ 17398602) coil could not shape as expected (the coil was stretched).They withdrew the coil and used a new coil to complete the procedure.There was no report of patient injury.It was reported that the device would be returned for analysis.
Additional Manufacturer Narrative
Conclusion: as reported by a healthcare professional, during the coil embolization, the orbit helical fill (637hf0208/ 17398602) coil could not shape as expected (the coil was stretched).They withdrew the coil and used a new coil to complete the procedure.There was no report of patient injury.It was reported that the device would be returned for analysis.A non-sterile orbit helical fill 2x8 was received coiled inside of a plastic bag.The hypotube was inspected and no damages were noted on it.The introducer was received unzipped without damaged.The support coil, gripper and the embolic coil were found outside of the introducer.The gripper and the embolic coil were inspected under microscope; no damages were noted on the gripper while the embolic coil was found stretched.A review of the manufacturing documentation associated with this lot 17398602 presented no issues during the manufacturing process that can be related to the reported complaint.A review of the manufacturing documentation associated with this lot 17398602 presented no issues during the manufacturing or inspection process that can be related to the reported complaint.The positioning difficulty could not be confirmed or evaluated.It appears that the condition of the embolic coil (stretched) may have contributed to the positioning difficulty.The confirmed stretched condition of the embolic coil was apparently caused by applying excessive force on the device, but it could not be conclusively determined.The cause of the stretched condition noted on the embolic coil was apparently caused by applying excessive force on the device, but it could not be conclusively determined.Neither the drh review nor the product analysis suggests that the failure experienced by the customer is related to the manufacturing process.Handling and procedural factors could be contributed to this condition.No corrective or preventive actions will be taken.

• 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: 6610633
• Report Number: 3008264254-2017-00067
• Device Sequence Number: 13455750
• Product Code: HCG
• UDI-Device Identifier: 10886704029687
• UDI-Public: (01)10886704029687(17)171231(10)17398602
• 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: 12/31/2017
• Device Catalogue Number: 637HF0208
• Device Lot Number: 17398602
• 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: 05/18/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/05/2017
• Supplement Report FDA Received Date: 06/27/2017
• Patient Sequence Number: 1