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

Catalog Number	M0035431030
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.During the analysis of the returned device, it was revealed that the main coil was broken and stretched.In addition, the coil delivery wire was kinked due to handling.During the functioning test, delivery wire moved independently to the main coil and the main coil was unable to be removed from the introducer sheath.Additional information provided by the customer indicated that no anomalies were noted to the device prior to use and there is no indication of a use error.It is probable that the device was damaged during the clinical procedure causing the reported event.An assignable cause of procedural factors will be assigned to the reported event and to the analyzed main coil broken and stretched, and coil introducer sheath friction.As the issue is associated with a product that meets stryker design and manufacture specifications and was used according to the dfu (direction for use) but due to procedural and/or anatomical factors during use, the device performance was limited.
Event or Problem Description
During the analysis of the returned device, it was revealed that the main coil was broken.No clinical consequences reported 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: 7724850
• Report Number: 3008881809-2018-00324
• Device Sequence Number: 1041040
• Product Code: HCG
• UDI-Device Identifier: 04546540698018
• UDI-Public: 04546540698018
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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
• Report Date (Section B): 07/26/2018

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: 12/31/2020
• Device Catalogue Number: M0035431030
• Device Lot Number: 20193652
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2018
• Initial Report FDA Received Date: 07/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR