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

Model Number	M0035432060
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2021
Type of Reportable Event	Malfunction
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 delivery wire was found to be kinked.The coil delivery wire was found broken.Functional test not carried out for main coil failed to detach due to the break on the delivery wire.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 customer indicated that no anomalies noted to the devices after prior to use and continuous flush was maintained.The device was returned for analysis and the proximal contact was noted to be intact, the coil delivery wire broken/ fractured which may have been perceived as the proximal contact broken.The main coil may would not have detached due to the broken coil delivery wire.It is probable that coil delivery wire was broken as a result of handling of the device during the clinical procedure, therefore an assignable cause of handling damage will be assigned to the as reported "main coil failed/unable to detach" and the as analyzed ''coil delivery wire broken/fractured and "coil delivery wire kinked/ bent".The as reported "coil proximal contact broken/fractured" will not be confirmed as the proximal contact was intact.The coil delivery wire was broken/ fractured which may have been perceived as the proximal contact broken.The as reported "coil proximal contact broken/fractured" will be assigned not confirmed.
Event or Problem Description
Analysis of the returned device found that the subject coil delivery wire broken/ fractured during use.There were no clinical consequences to the patient reported as a result of this event.

• Brand Name: TARGET HELICAL 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: 13209525
• Report Number: 3008881809-2022-00008
• Device Sequence Number: 4564313
• Product Code: HCG
• UDI-Device Identifier: 04546540676016
• UDI-Public: 04546540676016
• 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): 01/10/2022

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: 01/13/2024
• Device Model Number: M0035432060
• Device Catalogue Number: M0035432060
• Device Lot Number: 22662112
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/15/2021
• Initial Report FDA Received Date: 01/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/14/2021
• 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: EXCELSIOR SL-10 MICROCATHETER (STRYKER); INZONE DETACHMENT SYSTEM (STRYKER)
• Patient Age: 49 YR
• Patient Sex: Female
• Patient Race: Asian