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

Model Number	M0035431010
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned and the reported lot number was not confirmed as the packaging was not returned with the device.During visual inspection, the coil delivery wire was seen to be kinked/bent at the proximal contact junction and the main coil was seen detached.There was no coil returned with the device and was returned within a non stryker sheath.Unable to do a functional test as there was no coil returned.Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.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.It was found during product analysis that the subject coil prematurely detached, likely within the microcatheter.Additional information provided by the customer indicated that the patients anatomy was not tortuous, the device prepared as per the dfu, and continuous flush was maintained throughout procedure.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 will be assigned to the reported event of coil in catheter friction to the analyzed event of coil delivery wire kinked/bent and the main coil prematurely detached/separated during use, as the issue is 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
The device was returned for analysis and the investigation of the device revealed that the coil (subject device) prematurely detached, likely in the catheter.No clinical consequences were reported to the patient due to this event.

• Brand Name: TARGET HELICAL NANO 1MM X 1CM
• 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: 12530078
• Report Number: 3008881809-2021-00395
• Device Sequence Number: 4460766
• Product Code: HCG
• UDI-Device Identifier: 04546540700216
• UDI-Public: 04546540700216
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 09/24/2021

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: 08/26/2023
• Device Model Number: M0035431010
• Device Catalogue Number: M0035431010
• Device Lot Number: 22405044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/30/2021
• Initial Report FDA Received Date: 09/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Weight: 68