MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 ULTRA 2MM X 6CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035422060
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to the automated manufacturing execution system (mes), there are controls in the manufacturing process to ensure the product met specifications upon release.During the visual inspection, the coil delivery wire was found to be kinked/bent, the coil proximal contact was seen to be intact.The main coil was found to be detached/separated.Functional testing was not required.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 not confirmed, based on analysis.The device met specifications when received for complaint investigation, based on the analyzed anomalies noted to the device.The device was analyzed and the coil delivery wire was noted, to be kinked bent in numerous areas.The main coil was detached/separated, and the coil proximal contact was seen to be intact.An assignable cause of not confirmed.Will be assigned to the as reported (ar) coil proximal contact, broken/fractured as the device returned with the coil proximal contact intact.An assignable cause of procedural factors will be assigned to the as analyzed main coil prematurely detached/separated during use, and coil delivery wire kinked/bent as these defects 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 factors during use.
Event or Problem Description
Analysis of the returned device revealed, that the subject coil detached prematurely during use.There were no clinical consequences to the patient reported as a result of this event.And the procedure was completed successfully.

• Brand Name: TARGET 360 ULTRA 2MM X 6CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer (Section G): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 16928323
• Report Number: 3008881809-2023-00247
• Device Sequence Number: 12495211
• Product Code: HCG
• UDI-Device Identifier: 07613252239345
• UDI-Public: 07613252239345
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 05/14/2023

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: 06/10/2025
• Device Model Number: M0035422060
• Device Catalogue Number: M0035422060
• Device Lot Number: 23704623
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/25/2023
• Initial Report FDA Received Date: 05/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/12/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN MICROCATHETER
• Patient Sex: Unknown