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

Catalog Number	640CX2535
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/17/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is initial/final mdr report being submitted for this complaint with associated mfr# 3008264254-2017-00052, 3008264254-2017-00040 and 3008264254-2017-00041.Additional procode krd.(b)(4).A non-sterile orbit galaxy cmplx xtrasoft coil 2.5x3.5 was received coiled inside of a plastic bag.The hypotube was inspected and no damages were noted on it.The introducer was received zipped and no damages were noted on it.The support coil was found inside the introducer and no damages were noted on it.The gripper and the embolic coil were found outside of the introducer.The introducer, gripper and the embolic coil were inspected under microscope; the introducer and the gripper were found without damage while the embolic coil was found stretched.The introducer can be un-zipped and re-zipped without problem.A review of the manufacturing documentation associated with this lot 17152125 presented no issues during the manufacturing process that can be related to the reported complaint.The failure reported by the customer as ¿coil introducer ¿ zipping difficulty re-zipping¿ was not confirmed.The stretched condition noted on the embolic coil was apparently caused by excessive force applied on the devices 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; procedural factors appear to have contributed to this failure.No corrective action will be taken at this time.
Event or Problem Description
As reported by a healthcare professional, during the procedure two orbit galaxy complex fill 4x10 coils stretched.The physician removed the two stretched coils safely.Another orbit galaxy xtrasoft 2.5 x 3.5 coil failed to resheath when the physician tried to remove the coil, another coil of a different size was used.The procedure was completed.There were no serious injuries due to the reported event.It was initially reported that the complaint products are available for return.

• 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: 6566205
• Report Number: 3008264254-2017-00052
• Device Sequence Number: 926106
• Product Code: HCG
• UDI-Device Identifier: 10886704030676
• UDI-Public: (01)10886704030676(17)161130(10)17152125
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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
• Report Date (Section B): 03/17/2017

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: 11/30/2016
• Device Catalogue Number: 640CX2535
• Device Lot Number: 17152125
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2017
• Initial Report FDA Received Date: 05/15/2017
• Patient Sequence Number: 1