MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET HELICAL NANO 1MM X 3CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035431030
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/04/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
It was reported that the coil detached prematurely inside the microcatheter during manipulation.The coil was retrieved with a snare and the procedure was completed successfully.There were no reported clinical consequences to the patient.
Additional Manufacturer Narrative
Manufacturing date ¿ added.Device evaluated by mfg ¿updated.Summary attached - updated.Expiration date - added.Product available to stryker ¿ updated.Returned to manufacturer on ¿updated.The device history record review confirms that the device met all material, assembly and performance specifications.The subject device was returned with a snare device.The coil delivery wire was not returned for analysis.The main coil was returned snared within a third party device.Visual inspection of the device revealed that the main coil was kinked, stretched and prematurely detached/separated due to a physical break at the detachment zone.No other anomalies were noted.Functional testing could not be performed due to the damaged condition of the returned coil.Information available indicated that resistance was observed during advancement of the coil in the microcatheter.It is likely that the main coil was damaged during use thus limiting the performance of the coil during the clinical procedure.Therefore, an assignable cause of operational context has been assigned to this investigation.
Event or Problem Description
It was reported that the coil detached prematurely inside the microcatheter during manipulation.The coil was retrieved with a snare and the procedure was completed successfully.There were no reported clinical consequences to the patient.

• Brand Name: TARGET HELICAL NANO 1MM X 3CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 7147190
• Report Number: 3008881809-2017-00537
• Device Sequence Number: 1238184
• Product Code: HCG
• UDI-Device Identifier: 04546540698018
• UDI-Public: (01)04546540698018(17)180731(10)18518013
• Combination Product (Y/N): N
• PMA/510(K) Number: K113412
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2018
• Device Model Number: M0035431030
• Device Catalogue Number: M0035431030
• Device Lot Number: 18518013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2017
• Initial Date Received by Manufacturer: 12/04/2017
• Supplement Date Received by Manufacturer: 01/31/2018
• Initial Report FDA Received Date: 12/27/2017
• Supplement Report FDA Received Date: 02/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: EXCELSIOR MICROCATHETER(STRYKER)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR