MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 NANO 3 MM X 6 CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035443060
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device not returned.
Event or Problem Description
It was reported that during the procedure, the physician felt a strike when inserting the coil into the microcatheter and the delivery wire of the coil was broken.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.The subject device was not returned for analysis; therefore, visual, dimension and functional testing could not be performed.In case of this complaint, it is possible that the coil delivery wire broke while advancing through the microcatheter due to some handling issues or procedural factors encountered during use, possibly leading to the reported issue and the additional information provided by the customer indicated that no damage was noted to the device prior to use; therefore, an assignable cause of handling damage was assigned to the as reported issue 'nv ¿ coil delivery wire broken/fractured' 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.
Event or Problem Description
It was reported that during the procedure, the physician felt a strike when inserting the coil into the microcatheter and the delivery wire of the coil was broken.There were no clinical consequences to the patient reported due to this event.

• Brand Name: TARGET 360 NANO 3 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: 8076136
• Report Number: 3008881809-2018-00489
• Device Sequence Number: 1913457
• Product Code: HCG
• UDI-Device Identifier: 07613252600329
• UDI-Public: 07613252600329
• Combination Product (Y/N): N
• PMA/510(K) Number: K153658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2018

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: 04/23/2021
• Device Catalogue Number: M0035443060
• Device Lot Number: 20486461
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/23/2018
• Supplement Date Received by Manufacturer: 11/16/2018
• Initial Report FDA Received Date: 11/15/2018
• Supplement Report FDA Received Date: 12/10/2018
• 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 SL-10 MICROCATHETER (STRYKER)