MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET HELICAL ULTRA 3MM X 8CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035433080
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the physician encountered resistance when advancing the subject coil during the procedure, and upon removal, stretched and prematurely detached of the coil were noted.Another coil was used to complete the procedure successfully.No clinical consequences were reported due to this event.
Additional Manufacturer Narrative
Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the coil was returned detached/separated from the delivery wire and the main coil was found stretched.Functional testing was not required as the visual inspection confirmed the reported defects.The reported event is covered in the device directions for use (dfu).As well, the risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.Additional information provided by the physician indicated that the coil was stretched when used and the procedure was completed with another of the same device.The device was returned, and the main coil had been detached from the delivery wire and stretched.It is probable that the main coil was stretched and detached within the microcatheter due to procedural or anatomical factors during use.An assignable cause of procedural factors was assigned to the as reported and analyzed issues main coil stretched and main coil prematurely detached/separated during use and to the as reported issue coil in catheter friction as the issues are associated with a product that meets stryker design and manufacture specifications and was used in according with the dfu but due to procedural and/or anatomical factors during use, the product performance was limited.
Event or Problem Description
It was reported that the physician encountered resistance when advancing the subject coil during the procedure, and upon removal, stretched and prematurely detached of the coil were noted.Another coil was used to complete the procedure successfully.No clinical consequences were reported due to this event.

• Brand Name: TARGET HELICAL ULTRA 3MM X 8CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• MDR Report Key: 12033635
• Report Number: 3008881809-2021-00265
• Device Sequence Number: 4154320
• Product Code: HCG
• UDI-Device Identifier: 04546540676085
• UDI-Public: 04546540676085
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• 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): 09/08/2021

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: 09/20/2023
• Device Model Number: M0035433080
• Device Catalogue Number: M0035433080
• Device Lot Number: 22459240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2021
• Initial Date Received by Manufacturer: 05/26/2021
• Supplement Date Received by Manufacturer: 08/17/2021
• Initial Report FDA Received Date: 06/21/2021
• Supplement Report FDA Received Date: 09/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 58