MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 NANO 2MM X 4CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035442040
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the resistance encountered when inserting the subject coil into the microcatheter and the delivery wire of the subject coil was completely torn from the fluoro-saver marker part.Recalled as the breakage was abnormal, and the subject coil was no longer usable.No clinical consequences were reported to the patient due to this event.No other information was provided.
Additional Manufacturer Narrative
The subject device is unavailable to manufacturer.
Event or Problem Description
It was reported that the resistance encountered when inserting the subject coil into the microcatheter and the delivery wire of the subject coil was completely torn from the fluoro-saver marker part.Recalled as the breakage was abnormal, and the subject coil was no longer usable.No clinical consequences were reported to the patient due to this event.No other information was provided.
Additional Manufacturer Narrative
D4 expiration date: added.D9/h3 product available to stryker: updated.D9 returned to manufacturer on: updated.H3 device evaluated by mfg: updated.H3 summary attached: updated.H4 manufacturing date: added.Due to the automated manufacturing execution system (mes) system there are controls in the manufacturing process to ensure the product met specifications upon release.During analysis the coil delivery wire was seen to be kinked bent and broken and the main coil was found to be detached from the coil delivery wire and not returned for device analysis.It probable the damage was caused to the device was due to handling and manipulation when the reported friction was felt through the clinical procedure.The functional testing could not be performed due to the condition of the returned device.The reported main coil difficulty inserting could not be confirmed; however, the analysis results are consistent with the reported event, the reported 'coil delivery wire broken/fractured during use' was confirmed during analysis.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.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 as analyzed as well as the as reported code 'coil delivery wire broken/fractured during use and the as analyzed code ¿coil delivery wire kinked/bent¿ assigned handling damage as it appears to be associated with handling of the product or portion of the product upon removal of the product from the packaging / preparation of the product prior to use.The as reported code ¿main coil difficulty inserting¿ and the as analyzed code ¿ main coil prematurely detached/separated during use¿ will be assigned procedural factors as this complaint 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.

• Brand Name: TARGET 360 NANO 2MM X 4CM
• 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: 14935481
• Report Number: 3008881809-2022-00329
• Device Sequence Number: 17565312
• Product Code: HCG
• UDI-Device Identifier: 07613252600299
• UDI-Public: 07613252600299
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 09/12/2022

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: 07/20/2024
• Device Model Number: M0035442040
• Device Catalogue Number: M0035442040
• Device Lot Number: 23052334
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/14/2022
• Supplement Date Received by Manufacturer: 08/19/2022
• Initial Report FDA Received Date: 07/06/2022
• Supplement Report FDA Received Date: 09/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/22/2021
• 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: 1018 MICROCATHETER (STRYKER); TARGET COIL (STRYKER)
• Patient Sex: Unknown