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

Model Number	M0035432020
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure the coil (subject device) was found prematurely detached in the catheter.The procedure was completed successfully.The patients medical condition was good.There were no clinical consequences to the patient.
Additional Manufacturer Narrative
The device was returned and the lot number was confirmed with the packaging returned with the device.During visual inspection, the main coil was not returned and was seen to be detached from the pusher wire.Functional inspection was not carried out due to the damage noted.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.The reported complaint was confirmed based on analysis.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.Additional information provided by the customer indicated that the device was confirmed to be in good condition during preparation/prior to use on the patient and was prepared as per the dfu, continuous flush was set up and maintained throughout the clinical procedure, the coil was not advanced or retracted with force, and the patient's anatomy was not tortuous.Analysis of the returned device revealed the main coil had been separated from the pusher wire.The main coil was not returned.Based on visual inspection, it appears the coil had been manually detached.In the case of this complaint, it is probable that the main coil was manipulated against resistance inside the microcatheter during use resulting in premature separation from the delivery wire.An assignable cause of procedural factors will be assigned to the event since this issue appears to be associated with a product that met stryker design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural and/or anatomical factors during use.
Event or Problem Description
It was reported that during the procedure the coil (subject device) was found prematurely detached in the catheter.The procedure was completed successfully.The patients medical condition was good.There were no clinical consequences to the patient.

• Brand Name: TARGET HELICAL ULTRA 2MM X 2CM
• 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: 10872031
• Report Number: 3008881809-2020-00352
• Device Sequence Number: 11486931
• Product Code: HCG
• UDI-Device Identifier: 04546540675989
• UDI-Public: 04546540675989
• 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,Followup
• Report Date (Section B): 01/21/2021

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: 03/19/2023
• Device Model Number: M0035432020
• Device Catalogue Number: M0035432020
• Device Lot Number: 22197110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2020
• Initial Date Received by Manufacturer: 11/05/2020
• Supplement Date Received by Manufacturer: 01/08/2021
• Initial Report FDA Received Date: 11/19/2020
• Supplement Report FDA Received Date: 01/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 48 YR