MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC TRUPUSH COIL PUSHER; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	632774X
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This initial mdr will be the only report submitted for mfr report #3008264254-2017-00140.The product has been forwarded to codman for evaluation and testing, however the analysis has not been completed.Additional information will be submitted within 30 days of receipt.
Event or Problem Description
It was reported by a healthcare professional that a trufill coil pusher (632-774x/10764494) was used during a procedure when the ptfe sleeve sheared off of the coil pusher while inside the patient.There was no damage noted to the devices prior to use.There were no adverse events to the patient as a result of this event and there was no delay in procedure.The patient's information is not available.The device is being returned for evaluation.Reportedly, the patient is currently doing fine.
Additional Manufacturer Narrative
This final mdr will be the only report submitted for mfr report #3008264254-2017-00140.A non-sterile trufill coil pusher, dual mark was received coiled inside of a pouch.The wire was inspected and can be observed the coat (ptfe sleeve) was found peeled.The core wire was inspected under a vision system; the ptfe presented evidence of several scratches, due to the conditions that present the ptfe is probably that the guide wire had friction with an unknown object and in consequence ptfe was separated from the guide wire.The device history records were reviewed relative to the manufacturing, inspecting and packaging of lot 10764494.The history records indicate this product was final inspection tested and was determined to be acceptable.The failure reported by the customer as ¿embolic coil pusher - fractured-during use¿ was confirmed.Due to the condition of the received device it is not possible to determine the exact moment and cause of how it happened.The ptfe sleeve was found peeled.The cause of the peeled section of the ptfe might be provoked by the friction with another device; however, this could not be conclusively determined.Neither the analysis nor the dhr suggest that the failure reported could be related to the enterprise manufacturing process.There is no current safety signal identified related to the reported event based on review of complaint history for the device.No corrective action will be taken at this time.

• Brand Name: TRUPUSH COIL PUSHER
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA
• MDR Report Key: 6957644
• Report Number: 3008264254-2017-00140
• Device Sequence Number: 11040690
• Product Code: HCG
• UDI-Device Identifier: 10886704029168
• UDI-Public: (01)10886704029168(17)190111(10)10764494
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K123560
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2017

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: 01/11/2019
• Device Catalogue Number: 632774X
• Device Lot Number: 10764494
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2017
• Initial Date Received by Manufacturer: 09/20/2017
• Supplement Date Received by Manufacturer: 10/26/2017
• Initial Report FDA Received Date: 10/18/2017
• Supplement Report FDA Received Date: 11/17/2017
• Patient Sequence Number: 1