MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET HELICAL NANO 1.5MM X 4CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035431540
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/06/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
It was reported that after the coil was introduced into the aneurysm, the physician decided to resheath the coil to be re-introduced into the microcatheter.The coil broke off at the junction of the microcatheter during re-introduction.The physician cut the hub of the microcatheter to retrieve the broken coil.There were no reported clinical consequences to the patient.
Additional Manufacturer Narrative
The device history record review confirms that the device met all material, assembly and performance specifications.The subject device is not available; therefore, functional testing as well as physical analysis cannot be performed.The cause of the reported issue could not be definitively determined.
Event or Problem Description
It was reported that after the coil was introduced into the aneurysm, the physician decided to resheath the coil to be re-introduced into the microcatheter.The coil broke off at the junction of the microcatheter during re-introduction.The physician cut the hub of the microcatheter to retrieve the broken coil.There were no reported clinical consequences to the patient.

• Brand Name: TARGET HELICAL NANO 1.5MM X 4CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 6074671
• Report Number: 3008881809-2016-00245
• Device Sequence Number: 13675024
• Product Code: HCG
• UDI-Device Identifier: 04546540698056
• UDI-Public: (01)04546540698056(17)190831(10)19214509
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K093142
• 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): 01/30/2017

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: 08/31/2019
• Device Catalogue Number: M0035431540
• Device Lot Number: 19214509
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/07/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/02/2016
• Supplement Report FDA Received Date: 01/30/2017
• 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)