MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 ULTRA 2MM X 3CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035422030
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is not available to manufacturer.
Event or Problem Description
It was reported that during the procedure, the physician couldn't see the coil (subject device) under fluoroscopy.The physician removed the catheter and flushed it and found that the subject coil had prematurely detached inside the microcatheter.The procedure was not completed successfully.No clinical consequences were reported to the patient due to this event.
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 proximal contact wire and the coil delivery wire were intact.The main coil was attached and the distal tip was found to be intact.The main coil was noted to be stretched and the suture was damaged.The device was placed under an xray machine and images were taken, the coil was seen under fluoroscopy.During the functional inspection, there was friction when advancing the coil in the returned introducer sheath.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 not confirmed based on analysis.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.Additional information provided by the customer indicated that the device was confirmed to be in good condition during preparation/prior to use on the patient and was prepared as per the dfu, continuous flush was set up and maintained throughout the clinical procedure, and the coil was not advanced or retracted with force.An assignable cause of not confirmed will be assigned to the reported events since these issues included a returned product review (visual, physical, and/or performance testing) which showed no evidence of either the alleged issue(s) or any defect which could have contributed to the event.An assignable cause of procedural factors will be assigned to the as analyzed events since these issues appear to be associated with a product that met 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.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.
Event or Problem Description
It was reported that during the procedure, the physician couldn't see the coil (subject device) under fluoroscopy.The physician removed the catheter and flushed it and found that the subject coil had prematurely detached inside the microcatheter.The procedure was not completed successfully.No clinical consequences were reported to the patient due to this event.

• Brand Name: TARGET 360 ULTRA 2MM X 3CM
• 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: 10222225
• Report Number: 3008881809-2020-00192
• Device Sequence Number: 595251
• Product Code: HCG
• UDI-Device Identifier: 04546540675835
• UDI-Public: 04546540675835
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 09/01/2020

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: 11/05/2022
• Device Model Number: M0035422030
• Device Catalogue Number: M0035422030
• Device Lot Number: 21884190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2020
• Initial Date Received by Manufacturer: 06/12/2020
• Supplement Date Received by Manufacturer: 08/10/2020
• Initial Report FDA Received Date: 07/01/2020
• Supplement Report FDA Received Date: 09/01/2020
• 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 SL-10 90 MICROCATHETER (STRYKER); EXCELSIOR SL-10 S SHAPED MICROCATHETER (STRYKER); TARGET 360 ULTRA COIL (STRYKER)
• Patient Age: 58 YR