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

Model Number	M0036123090
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2021
Type of Reportable Event	Malfunction
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 subject coil delivery wire was seen to be kinked/bent and broken/fractured.The main coil was seen to be kinked/bent.A functional test was unable to perform due to damage of delivery wire.The reported complaint was confirmed based on analysis.The device failed to meet specification 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.Additional information indicates 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, the device was prepared for use as per the directions for use.The delivery wire and the introducer sheath were taken out together from the dispenser hoop and there was no resistance when the coil was taken out of dispenser hoop.There was no friction or resistance while the coil was advancing in the introducer sheath.The rhv was opened enough to allow passage of the device through without damage and the coil was advanced slowly and gently.No excessive force was applied while advancing the coil.No torque was given when advancing the delivery wire.The middle part of the coil stretched.The patient¿s anatomy was normal tortuous.The damage noted to the device would be indicative of the as reported event.While the main coil was not stretched, it was kinked and the delivery wire was fractured and kinked which indicates the device encountered a significant resistance inside the patient.Therefore the as reported main coil stretched and as analyzed coil delivery wire broken/fractured during use and main coil kinked/bent will be assigned procedural factors as these defects 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 or anatomical factors during use.The as analyzed coil delivery wire kinked/bent will be assigned handling damage 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.
Event or Problem Description
It was initially reported that during the repositioning the coil into the aneurysm, stretched was noted at the main coil.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.Analysis of the returned device found that the subject main coil was kinked and the coil delivery wire was broken/fractured during use.There were no clinical consequences to the patient reported as a result of this event.

• 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
• MDR Report Key: 12221943
• Report Number: 3008881809-2021-00309
• Device Sequence Number: 19592019
• 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
• Report Date (Section B): 07/23/2021

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: 09/09/2023
• Device Model Number: M0036123090
• Device Catalogue Number: M0036123090
• Device Lot Number: 22432479
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/29/2021
• Initial Report FDA Received Date: 07/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1