MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 ULTRA 4MM X 10CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035424100
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is not available to manufacturer.
Event or Problem Description
It was reported that during the procedure, the coil (subject device) failed to detach upon multiple detachment attempts.The physician attempted to remove and reinsert the subject coil and found the delivery wire to be kinked.The physician attempted to make the delivery wire straight but it fractured during the attempt.The physician 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 the procedure, the coil (subject device) failed to detach upon multiple detachment attempts.The physician attempted to remove and reinsert the subject coil and found the delivery wire to be kinked.The physician attempted to make the delivery wire straight but it fractured during the attempt.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.
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 proximal contact wire was broken and the coil delivery wire was kinked/bent.The coil delivery wire was severely stretched and damaged.The distal tip was found to be intact and the main coil was stretched.During functional inspection, the main coil was placed in a detachment jar filled with saline.The proximal contact was placed into the demo inzone device.The green ready light illuminated and the detach button was pushed.The detachment cycle was completed and the main coil did not detach.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 no anomalies noted to the devices after prior to use and continuous flush was maintained.It is probable that the proximal contact was broken as a result of handling of the device and the delivery wire was also damaged as a result of handling during the clinical procedure, therefore an assignable cause of "handling damage" will be assigned to reported/analysed main coil failed/unable to detach, coil delivery wire kinked/bent, as well as the analysed coil proximal contact broken/fractured and coil delivery wire damaged.Inspection of device confirmed the coil proximal contact broken/fractured '; therefore "not confirmed" will be assigned to the reported coil delivery wire broken/fractured during use.It is probable that the main coil was stretched during the clinical procedure.An assignable cause of procedural factors will be assigned to the analysed main coil stretched, as the issue is associated with a product that meets design and manufacture specifications and was used in according with the dfu but due to procedural and/or anatomical factors during use, the device performance was limited.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.

• Brand Name: TARGET 360 ULTRA 4MM X 10CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• MDR Report Key: 10449065
• Report Number: 3008881809-2020-00243
• Device Sequence Number: 11676511
• Product Code: HCG
• UDI-Device Identifier: 07613252192336
• UDI-Public: 07613252192336
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• 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): 10/15/2020

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: 12/30/2022
• Device Model Number: M0035424100
• Device Catalogue Number: M0035424100
• Device Lot Number: 22026650
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2020
• Initial Date Received by Manufacturer: 08/03/2020
• Supplement Date Received by Manufacturer: 09/21/2020
• Initial Report FDA Received Date: 08/25/2020
• Supplement Report FDA Received Date: 10/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ENCHON10 MICROCATHETER (MEDTRONIC); EXCELSIOR XT-27 MICROCATHETER (STRYKER); EXCELSIOR XT-27 MICROCATHETER (STRYKER); INZONE DETACHMENT SYSTEM (STRYKER); NEUROFORM EZ STENT (STRYKER); NEUROFORM EZ STENT (STRYKER); EXCELSIOR XT-27 MICROCATHETER (STRYKER); INZONE DETACHMENT SYSTEM (STRYKER); NEUROFORM EZ STENT (STRYKER)
• Patient Age: 53 YR