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

Model Number	M0035432060
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/04/2017
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 main coil was stretched and subsequently broken (along with the suture) due to some procedural/anatomical factors encountered during use.The additional information states that the coil was repositioned.It is possible that the coil got stuck inside the microcatheter and it was removed with an excessive force which contributed to the coil to become stretched and broke.However; it cannot be conclusively determined.In addition, the coil delivery wire was found to be kinked and it¿s likely due to handling.A functional test could not be performed due to the condition of the returned device.Based on the review of the information indicated that the device was in a good condition after unpacking and preparation.As the issue is associated with a product that meets stryker design and manufacture specifications and was used in according with the device direction for use (dfu) but due to procedural and/or anatomical factors during use, the device performance was limited.An assignable cause of operational context has been assigned to the reported event.
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 ULTRA 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: 7071269
• Report Number: 3008881809-2017-00501
• Device Sequence Number: 1119081
• Product Code: HCG
• UDI-Device Identifier: 04546540676016
• UDI-Public: (01)04546540676016(17)191031(10)19386680
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: K102672
• 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): 11/30/2017

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: 10/31/2019
• Device Model Number: M0035432060
• Device Catalogue Number: M0035432060
• Device Lot Number: 19386680
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2017
• Initial Report FDA Received Date: 11/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Weight: 49