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

Catalog Number	640CF0308
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/24/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is initial/final mdr submitted for this complaint with associated mfr# 3008264254-2017-00031.(b)(4).A non-sterile orbit galaxy cmplx fill coil 3x8 was received coiled inside of a coil plastic bag.In the same plastic bag, an unknown micro catheter was received and no obvious damages were noted on it.The hypotube was inspected and it was found kinked at 63cm from the proximal end.The introducer was received kinked and residues of dry blood can be observed on it.The support coil, gripper and just the head piece of the embolic coil was found outside of the introducer.The gripper and just the head piece of the embolic coil were inspected under microscope and no damages were noted on them.The rest of the embolic coil was found inside of the unknown micro catheter; the embolic coil was removed from the unknown micro catheter and it was found stretched and the suture on it was found broken; the edges of the broken section show evidence that appear that it was elongated before it was broken.A review of the manufacturing documentation associated with this lot 17579466 presented no issues during the manufacturing process that can be related to the reported complaint.The failure reported by the customer as ¿coil ¿ impeded¿ could not be evaluated as the embolic coil was found separated from the unit.Neither the dhr review nor the product analysis suggests that the failure experienced by the customer is related to the manufacturing process, handling and procedural factors could have contributed to this condition.No corrective or preventive actions will be taken.
Event or Problem Description
As reported by a health care professional, during coil embolization of an aneurysm, the physician experienced resistance when using an orbit galaxy complex fill 3x8 coil.The patient¿s vessels were moderately torturous and not calcified.The og cmplx fill (complaint product) was inserted into the micro catheter (competitor¿s device) but there was resistance felt and coil could not be detached.Therefore the coil was replaced with another one (same size, galaxy) and it was used with the same micro catheter.The procedure was successfully completed without further issues or delay.There were no patient injuries or complications reported.The complaint product was new and stored per labeling instructions.The procedure was conducted in accordance with the ifu and a constant flush was maintained at all times.No visible defect or damage was noted on the products prior to (and after) the event.No unintended detachment was observed in the vessel or in the microcatheter.The product will be returned for the investigation.No further information is available.

• Brand Name: ORBIT GALAXY DETACHABLE COIL SYSTEM
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA
• MDR Report Key: 6394641
• Report Number: 3008264254-2017-00031
• Device Sequence Number: 10927300
• Product Code: HCG
• UDI-Device Identifier: 10886704030225
• UDI-Public: (01)10886704030225(17)180831(10)17579466
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 01/24/2017

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: 08/31/2018
• Device Catalogue Number: 640CF0308
• Device Lot Number: 17579466
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2017
• Initial Report FDA Received Date: 03/10/2017
• Patient Sequence Number: 1