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

Catalog Number	640HX0204
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/15/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is initial mdr report submitted with associated mfr# 3008264254-2017-00104.(b)(4).The product is available for evaluation and testing, however the analysis has not been completed.Additional information will be submitted within 30 days of receipt.No conclusions are made at this time.
Event or Problem Description
It was reported by a healthcare professional that a og helical xtrsoft coil 2x4 (640hx0204/ 17507918) was found to be stretched before use.A new coil was used to complete the procedure.There was no report on the patient injury.There were no delays or interventional treatment due to the event.There were no damages noted on the inner product pouch, outer product box or the shipping box.It was initially reported that the complaint product is available for return.
Additional Manufacturer Narrative
This is final mdr report submitted with associated mfr# 3008264254-2017-00104.A non-sterile og helical xtrsoft coil 2x4 was received coiled inside of a plastic bag.No damages were noted on the hub.The hypotube was inspected and it was found without any damage.The introducer was received zipped and it was found without damage.The support coil, gripper and embolic coil were received inside introducer.The support coil was inspected and it was found without damage.The gripper and embolic coil were inspected under vision system; no damages were noted on the gripper while the embolic coil was found stretched.The suture of the embolic coil was found broken.A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection process that can be related to the reported complaint.The failure reported by the customer as ¿coil - unraveled/stretched¿ was confirmed.The condition found on the embolic coil was possibly caused by excessive force applied on the device but it could not be conclusively determined.Neither the analysis nor the dhr suggest that the failure reported could be related to the manufacturing process; handling and procedural factors appear to have contributed to this failure.Therefore, no corrective action will be taken at this time.There is no current safety signal identified related to the reported event based on review of complaint history for the device.

• Brand Name: XTRASOFT ORBIT GALAXY DETACHABLE COIL
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA
• MDR Report Key: 6690066
• Report Number: 3008264254-2017-00104
• Device Sequence Number: 10774782
• Product Code: HCG
• UDI-Device Identifier: 10886704030713
• UDI-Public: (01)10886704030713(17)180531(10)17507918
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2017

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: 05/31/2018
• Device Catalogue Number: 640HX0204
• Device Lot Number: 17507918
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2017
• Initial Date Received by Manufacturer: 06/15/2017
• Supplement Date Received by Manufacturer: 08/02/2017
• Initial Report FDA Received Date: 07/06/2017
• Supplement Report FDA Received Date: 08/03/2017
• Patient Sequence Number: 1