MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XXL 360 6MM X 40CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0036180640
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2021
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 was returned with a non-stryker (terumo) microcatheter.The coil delivery wire was seen to be kinked/bent by the proximal contact and the main coil was returned detached/separated from the delivery wire.During functional testing, the introducer sheath distal tip was positioned into the hub of the returned non-stryker (terumo) microcatheter.The distal tip of the introducer sheath did not sit into the proximal end of the microcatheter shaft and there was a visible gap.A patency mandrel was advanced through the non-stryker (terumo) microcatheter and the detached main coil exited the catheter.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 there was no damage noted to the packaging prior to opening, 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 during the clinical procedure.There was no friction / resistance felt when the coil was advanced through the introducer sheath.It is unclear if the friction was felt when it was loaded into the catheter hub or more distally in the catheter shaft.During analysis, the delivery wire was found to be kinked at one location and the coil was detached and present inside the non-stryker (terumo) catheter which was returned as part of the complaint.There was no other damage visible to the main coil.Most notably, there was a gap present when the introducer sheath was placed into the terumo catheter hub.This is likely to have been a significant contributing factor in the case of this complaint.Based on the event description and analysis, the as reported issues can be confirmed.The as reported codes and as analyzed codes (with the exception of coil delivery wire kinked/bent) was assigned procedural factors as this complaint appears 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 and/or anatomical factors during use.An assignable cause of handling damage was assigned to the as analyzed issues coil delivery wire kinked/bent as it is most likely that this damage to the delivery wire occurred due to handling of the device during use.
Event or Problem Description
Analysis of the returned device found that the subject coil was prematurely detached during use.There was no clinical consequences to the patient as a result of this event.

• Brand Name: TARGET XXL 360 6MM X 40CM
• 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: 12356445
• Report Number: 3008881809-2021-00342
• Device Sequence Number: 17347241
• Product Code: HCG
• UDI-Device Identifier: 07613327466409
• UDI-Public: 07613327466409
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/23/2021

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: 04/02/2023
• Device Model Number: M0036180640
• Device Catalogue Number: M0036180640
• Device Lot Number: 22170624
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/26/2021
• Initial Report FDA Received Date: 08/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1