MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XXL 360 10MM X 40CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0036181040
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device not returned for evaluation.
Event or Problem Description
It was reported that during the procedure the coil (subject device) prematurely detached while it was attempted to insert several times by pushing and pulling inside the microcatheter.The subject coil was collected with a snare device and the procedure was completed successfully.There were no clinical consequences to the patient.No further information is available.
Event or Problem Description
It was reported that during the procedure the coil (subject device) prematurely detached while it was attempted to insert several times by pushing and pulling inside the microcatheter.The subject coil was collected with a snare device and the procedure was completed successfully.There were no clinical consequences to the patient.No further information is available.
Additional Manufacturer Narrative
The device was returned and the lot number was confirmed with the packaging returned with the device.During visual inspection, the main coil was manually detached and was not returned.The proximal contact wire was intact and the coil delivery wire was kinked/bent.Functional testing was not performed as the coil was not returned.Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.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.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.In the case of this complaint, it is likely that the user experienced friction in the microcatheter due to procedural factors during use and as a result of pushing and pulling against resistance, the main coil prematurely separated inside the catheter.An assignable cause of procedural factors will be assigned to the subject coil detaching and the friction that was felt in the catheter since these issues 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 and/or anatomical factors during use.An assignable cause of handling damage will be assigned to the coil delivery wire being kinked/bent since this issue is likely due to handling of the device during the clinical procedure.

• Brand Name: TARGET XXL 360 10MM X 40CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; IE NA
• MDR Report Key: 10227292
• Report Number: 3008881809-2020-00193
• Device Sequence Number: 595252
• Product Code: HCG
• UDI-Device Identifier: 07613327128406
• UDI-Public: 07613327128406
• Combination Product (Y/N): N
• 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,Followup
• Report Date (Section B): 09/08/2020

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: 05/18/2022
• Device Model Number: M0036181040
• Device Catalogue Number: M0036181040
• Device Lot Number: 21405180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2020
• Initial Date Received by Manufacturer: 06/25/2020
• Supplement Date Received by Manufacturer: 08/24/2020
• Initial Report FDA Received Date: 07/02/2020
• Supplement Report FDA Received Date: 09/08/2020
• 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: EXCELSIOR 1018 CATHETER (STRYKER); EXCELSIOR 1018 MICROCATHETER (STRYKER)