MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET HELICAL NANO 2 MM X 6 CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035452060
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device not returned.
Event or Problem Description
It was reported that during the procedure, the coil was prematurely detached in the microcatheter hub, outside the patient¿s body.There were no clinical consequences to the patient reported due to this event.
Additional Manufacturer Narrative
The device history record (dhr) review confirms that the device met all material, assembly and performance specifications.During visual inspection, the proximal contact wire and the distal tip of the coil were found to be intact.The coil delivery wire and the main coil were noted to be kinked/bent.During functional testing, friction was encountered when advancing the coil though the introducer sheath.In case of this complaint, the returned coil was seen to be kinked/bent but was not broken; therefore, the reported event was not confirmed.The damage noted to the coil was causing friction in the introducer sheath.An assignable cause of procedural factor was assigned to the as analyzed defect 'nv - main coil kinked bent', and 'nv - coil introducer sheath friction', as the issue is associated with a product that meets stryker design and manufacture specifications and was used in accordance with the direction for use (dfu) but due to procedural and/or anatomical factors during use, the device performance was limited.During investigation, it was noted that the coil delivery wire was kinked/bent.It is probable that during the procedure, force was applied to the device, possibly when it was stated the device was pulled back, and this caused the damage to the delivery wire.An assignable cause of handling damage was assigned to the as analyzed defect 'nv - coil delivery wire kinked bent', as the issue is due to handling of the device or portion of the device during the clinical procedure, upon removal of the device from the packaging, or preparation of the device prior to use.The product investigation confirmed that the delivery wire was kinked/bent but not fractured.It is highly unlikely that the kinked/bent delivery wire may contribute to and/or cause any patient injury.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.Expiration date: added.Manufacturing date: added.Product available to stryker: updated.Device evaluated by mfg: updated.Summary attached: updated.
Event or Problem Description
It was reported that during the procedure, the coil was prematurely detached in the microcatheter hub, outside the patient¿s body.There were no clinical consequences to the patient reported due to this event.

• Brand Name: TARGET HELICAL NANO 2 MM X 6 CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 8065410
• Report Number: 3008881809-2018-00484
• Device Sequence Number: 1745377
• Product Code: HCG
• UDI-Device Identifier: 07613252600381
• UDI-Public: 07613252600381
• Combination Product (Y/N): N
• Initial Reporter Country: KR
• PMA/510(K) Number: K153658
• 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): 01/09/2019

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: 04/07/2022
• Device Catalogue Number: M0035452060
• Device Lot Number: 20399150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2018
• Initial Date Received by Manufacturer: 10/22/2018
• Supplement Date Received by Manufacturer: 12/24/2018
• Initial Report FDA Received Date: 11/13/2018
• Supplement Report FDA Received Date: 01/10/2019
• 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 SL-10 MICROCATHETER (STRYKER)