MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 NANO 1.5MM X 2CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	23426988
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
It was reported that during pcoma (posterior communicating artery) aneurysm embolization case, after the coil (subject device) was delivered to go into aneurysm, the operator pulled it back a little for adjustment and when the it reached tip of the microcatheter, it detached unexpectedly.The operator replaced it with a new device and continued the procedure without clinical consequences to the patient.
Event or Problem Description
It was reported that during pcoma (posterior communicating artery) aneurysm embolization case, after the coil (subject device) was delivered to go into aneurysm, the operator pulled it back a little for adjustment and when the it reached tip of microcatheter it detached unexpectedly.The operator replaced it with a new device and continued the procedure without clinical consequences to the patient.
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 test, the coil delivery wire kinked/bent, the main coil was found to be stretched, and the main coil was found to be detached/separated.A functional test was not performed as the reported event was confirmed during visual; analysis.The reported complaint was confirmed during device analysis.The device failed to meet specifications when received for complaint investigation based on damage noted to the device during the analysis.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 the device prepared for use as per the directions for use, there was no damage noted to the packaging prior to opening the packaging, the device was confirmed to be in good condition during preparation/prior to use on the patient and continuous flush was set up and maintained throughout the clinical procedure.The device was returned for analysis and the coil delivery wire was noted to be kinked/bent.The main coil was returned detached.The main coil was stretched.It is probable that these abnormalities were caused as a result of handling of the device during the clinical procedure, therefore an assignable cause of handling damage will be assigned to the reported and analyzed ¿main coil prematurely detached/separated during use¿ and the analyzed ¿coil delivery wire kinked/ bent.¿ the as analyzed 'main coil stretched¿ will be assigned procedural factors as this 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 product performance was limited.

• Brand Name: TARGET 360 NANO 1.5MM X 2CM
• 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: 15874219
• Report Number: 3008881809-2022-00593
• Device Sequence Number: 19465972
• Product Code: HCG
• UDI-Device Identifier: 04546540697981
• UDI-Public: 04546540697981
• 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,Followup
• Report Date (Section B): 12/21/2022

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: 01/17/2025
• Device Model Number: 23426988
• Device Catalogue Number: M0035421520
• Device Lot Number: 23426988
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/02/2022
• Supplement Date Received by Manufacturer: 12/14/2022
• Initial Report FDA Received Date: 11/28/2022
• Supplement Report FDA Received Date: 12/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/19/2022
• 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: 7F GUIDE CATHETER (NON-STRYKER); SL-10 CATHETER (STRYKER); TARGET COIL (STRYKER); XT-27 CATHETER (STRYKER)
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Race: Asian