MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 SOFT 5MM X 15CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0036125150
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The subject coil was returned for analysis and the device investigation revealed that it prematurely detached during use in the patient.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
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 device was returned and the lot number was confirmed with the packaging returned with the device.During functional inspection, the coil delivery wire was seen kinked/bent and the main coil was seen detached from the delivery wire.The coil introducer sheath was found intact and the main coil was not returned.Functional testing was not performed as that main coil was not returned.Additional information indicated that the coil wouldn't advance into the microcatheter and was stuck inside the microcatheter.The reported event of coil in catheter friction 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 the analyzed anomalies noted to the device.During analysis, the delivery wire was seen to be kinked/bent, the main coil was seen to be detached from the delivery wire and was not returned for analysis.An assignable cause of procedural factors will be assigned to the as reported event coil in catheter friction as well as the analyzed event of main coil prematurely detached/separated during use as these issues appear 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.An assignable cause of handling damage will be assigned to the as analyzed event coil delivery wire kinked/bent as the issue is due to handling of the product or portion of the product during the clinical procedure, upon removal of the product from the packaging, or preparation of the product prior to use.

• Brand Name: TARGET XL 360 SOFT 5MM X 15CM
• 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: 15625247
• Report Number: 3008881809-2022-00510
• Device Sequence Number: 17728610
• Product Code: HCG
• UDI-Device Identifier: 07613327128291
• UDI-Public: 07613327128291
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 10/18/2022

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: 08/04/2024
• Device Model Number: M0036125150
• Device Catalogue Number: M0036125150
• Device Lot Number: 23056664
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/28/2022
• Initial Report FDA Received Date: 10/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/06/2021
• 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
• Patient Sex: Unknown