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

Model Number	M0036123090
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/18/2020
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.Device was returned for analysis, product lot number was not confirmed as packaging was not returned with device.During visual inspection, the subject main coil was returned detached from the coil delivery wire and the delivery wire was not returned.Subject main coil was noted to be kinked and main coil was seen to be broken at the detachment zone.The subject coil suture had remained intact.Functional testing was not conducted as it could not be performed with main coil detached upon return.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.As per the additional information, the device was prepared per the dfu and continuous flush was maintained throughout the procedure.The damaged noted to the device would be indicative of the reported event.It was seen that the main coil was kinked and broken at the detachment zone which would indicate significant friction was encountered in the microcatheter which subsequently led to the coil breaking during device withdrawal.As a result, the reported event can be confirmed of coil in catheter friction can be confirmed and the reported event of main coil stretched cannot be confirmed as the returned subject coil was not stretched.Therefore, the reported and analyzed events 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.
Event or Problem Description
It was reported that during the procedure, physician noted resistance when inserting initial coil through microcatheter.Physician managed to detain coil but was unable to detach coil with detachment system.Product was replaced with subject coil and resistance was met within microcatheter.Upon withdrawal subject coil was noted to be stretched by the physician.Subject coil was replaced and procedure continued successfully without clinical consequence to the patient.Analysis of the returned device noted that the subject coil had fractured during use.Therefore, this event meets reporting criteria with an awareness date of 30-jun-2020.The event will be assessed to reflect the decision change and emdr will be filed accordingly.

• 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 ; IE NA
• MDR Report Key: 10323841
• Report Number: 3008881809-2020-00220
• Device Sequence Number: 11725919
• Product Code: HCG
• UDI-Device Identifier: 07613327128284
• UDI-Public: 07613327128284
• Combination Product (Y/N): N
• Initial Reporter Country: JP
• 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): 07/24/2020

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: 08/25/2022
• Device Model Number: M0036123090
• Device Catalogue Number: M0036123090
• Device Lot Number: 21690122
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/30/2020
• Initial Report FDA Received Date: 07/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1