MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XXL 360 24MM X 50CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0036182450
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2021
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 coil delivery wire was found to be kinked/bent at the weld junction.The main coil was found to be detached from the delivery wire.The proximal contact and the main coil were found to be intact.Functional test for reported events, coil difficult to remove/withdraw from catheter and coil in catheter friction, were unable to perform as the main coil was found to be detached.The reported events could not be confirmed; however, the analysis results are consistent with the reported events.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.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 damage was noted to the packaging prior to opening the packaging.The device was prepared for use as per the directions for use.However, continuous flush was not set up and maintained throughout the clinical procedure.The patients anatomy was described as 'very meandering'.The tapered distal end of the introducer sheath was firmly seated in the hub of the non-stryker microcatheter.This complaint appears to be associated with a product that met stryker design and manufacturing specifications and was used in accordance with the dfu except that continuous flush was not set-up / maintained.Therefore, an assignable cause of user error will be assigned to the reported events and to the as analyzed event main coil prematurely detached/separated during use.An assignable cause of handling damage will be assigned to the to the as analyzed event coil delivery wire kinked/bent since this issue is likely due to handling of the device during the clinical procedure.
Event or Problem Description
The subject coil was returned for analysis and the device investigation revealed that the main coil prematurely detached/separated during use.No clinical consequences were reported to the patient due to this event.

• Brand Name: TARGET XXL 360 24MM X 50CM
• 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: 12441900
• Report Number: 3008881809-2021-00367
• Device Sequence Number: 11747196
• Product Code: HCG
• UDI-Device Identifier: 07613327128376
• UDI-Public: 07613327128376
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K161429
• 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): 09/08/2021

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: 12/22/2023
• Device Model Number: M0036182450
• Device Catalogue Number: M0036182450
• Device Lot Number: 22655932
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/18/2021
• Initial Report FDA Received Date: 09/08/2021
• 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: PROGRATE 2 MICROCATHETER (TERUMO); TARGET COILS (STRYKER)