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	07/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
It was reported that during the procedure the physician attempted to insert the subject coil but it got stuck inside the microcatheter and was unable to be pushed forward.So the physician decided to remove it and while removing the subject coil detached prematurely so it was taken out along with the microcatheter.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 physician attempted to insert the subject coil but it got stuck inside the microcatheter and was unable to be pushed forward.So the physician decided to remove it and while removing the subject coil detached prematurely so it was taken out along with the microcatheter.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.
Additional Manufacturer Narrative
H4 manufacturing date added.H3 device evaluated by mfg updated.H3 summary attached updated.D4 expiration date added.D9 product available to stryker updated.D9 returned to manufacturer on updated.Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.The device was returned with a non-stryker catheter.The lot number was not confirmed as the packaging was not returned with the device.During the visual inspection, a patency mandrel was advanced in the returned non-stryker catheter, a quantity of blood and the coil exited the catheter.The coil was returned detached.The proximal contact wire was intact.The coil delivery wire was kinked/bent.The distal tip was found to be intact.The main coil was intact.Functional testing was not carried out as the coil was detached.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 preparation/set-up was performed as per the dfu, continuous flush was maintained for the duration of the procedure, and there was no allegation against the microcatheter.A non-stryker microcatheter was returned with the subject device.During analysis, a patency mandrel was advanced through the microcatheter and the detached coil and a quantity of blood exited the catheter tip.The coil delivery wire was found to be kinked and it appeared the main coil had been manually detached.In the case of this complaint, it is likely that the user experienced friction when inserting the coil 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 as reported and as analyzed events 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 analyzed event coil delivery wire 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: 10280954
• Report Number: 3008881809-2020-00209
• Device Sequence Number: 485124
• 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): 09/10/2020

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: 11/25/2022
• Device Model Number: M0036181040
• Device Catalogue Number: M0036181040
• Device Lot Number: 21936480
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2020
• Initial Date Received by Manufacturer: 07/01/2020
• Supplement Date Received by Manufacturer: 08/24/2020
• Initial Report FDA Received Date: 07/15/2020
• Supplement Report FDA Received Date: 09/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1