MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 SOFT 3MM X 9CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0036123090
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not yet been returned for evaluation.
Event or Problem Description
It was reported during the procedure the coil (subject device) prematurely detached in the catheter.The device was removed with a snare.The subject device was replaced, and the procedure was completed successfully.There were no clinical consequences to the patient due to this event.
Event or Problem Description
It was reported during the procedure the coil (subject device) prematurely detached in the catheter.The device was removed with a snare.The subject device was replaced, and the procedure was completed successfully.There were no clinical consequences to the patient due to this event.
Additional Manufacturer Narrative
H4 manufacturing date ¿ added.H3 device evaluated by mfg ¿updated.H3 summary attached - updated.D4 expiration date - added.D9 product available to stryker ¿ updated.D9 returned to manufacturer on ¿updated.The device was returned and the lot number was confirmed with the packaging returned with the device.During visual inspection there was dried blood seen along the main coil.The main coil was seen to be stretched and kinked.The coil delivery wire was not returned.Functional test not carried out as coil was detached.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 reported complaint was confirmed based on analysis.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.Additional information provided by the customer indicated that the device was confirmed to be in good condition during preparation/prior to use on the patient and was prepared as per the dfu, continuous flush was set up and maintained throughout the clinical procedure, the rhv was opened enough to allow passage of the device through without damage, and the coil was advanced slowly and gently without applying excessive force.During analysis, the main coil was found to be kinked/bent and stretched.The coil was returned detached without the delivery wire.Based on the analysis, it is possible that the coil may have been advanced against friction in the microcatheter during the procedure which in turn could cause damage to the coil and premature detachment when the device was retracted.An assignable cause of procedural factors will be assigned to the as reported and analyzed event of the main coil prematurely detached/separated during use, the main coil stretched and the main coil kinked/bent since these issues are associated with a product that met stryker design and manufacturing specifications and was used in accordance with the dfu but due to procedural and/or anatomical factors during use, the product performance was limited.

• Brand Name: TARGET XL 360 SOFT 3MM X 9CM
• 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: 12325413
• Report Number: 3008881809-2021-00338
• Device Sequence Number: 19968927
• Product Code: HCG
• UDI-Device Identifier: 07613327128284
• UDI-Public: 07613327128284
• 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): 11/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/11/2024
• Device Model Number: M0036123090
• Device Catalogue Number: M0036123090
• Device Lot Number: 22720634
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/21/2021
• Supplement Date Received by Manufacturer: 10/27/2021
• Initial Report FDA Received Date: 08/16/2021
• Supplement Report FDA Received Date: 11/12/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/12/2021
• 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: SNARE (UNKNOWN); SNARE (UNKNOWN)
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 16 YR
• Patient Sex: Female
• Patient Race: Asian