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

Model Number	M0035422060
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to the automated mes (manufacturing execution system) system, there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the coil delivery wire was noted to be kinked/bent, the coil delivery wire was noted to be broken/fractured, and the main coil was noted to be kinked/bent and stretched.A functional test could not be performed due to damage.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 main coil failed/unable to detach could not be confirmed; however, the analysis results are consistent with the reported event.The device failed to meet specifications when received for complaint investigation based on damage noted to the device during the analysis.The device was returned for analysis, the delivery wire was noted to be kinked/bent and broken/fractured.The main coil was noted to be kinked/bent and stretched.The coil could not be detached during analysis due to damage noted to the returned device.It is probable that the main coil was damaged during the clinical procedure.An assignable cause of procedural factors will be assigned to the reported defect ¿main coil failed/unable to detach¿ and to the analyzed ¿main coil kinked/bent¿, ¿main coil stretched¿, 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 device performance was limited.The analyzed defects ¿coil delivery wire kinked/bent¿ and ¿coil delivery wire broken/fractured during use¿ will be assigned handling damage as these defects appear to be associated with handling of the product or portion of the product during the procedure, a probable cause of handling damage was assigned.
Event or Problem Description
It was reported that during procedure the coil (subject device) could not detach.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.Analysis of the returned device found the coil delivery wire broken/fractured.There were no clinical consequences to the patient reported as a result of this event.

• 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: 14520034
• Report Number: 3008881809-2022-00251
• Device Sequence Number: 6635166
• Product Code: HCG
• UDI-Device Identifier: 07613252239345
• UDI-Public: 07613252239345
• 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): 05/26/2022

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: 06/29/2024
• Device Model Number: M0035422060
• Device Catalogue Number: M0035422060
• Device Lot Number: 23011281
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/18/2022
• Initial Report FDA Received Date: 05/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2021
• 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: INZONE DETACHMENT SYSTEM (STRYKER); SL-10 CATHETER (STRYKER)
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 86 KG
• Patient Race: Asian