MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 STANDARD 16MM X 50CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0036101650
Medical Device Problem Codes	Physical Resistance/Sticking (4012); Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/28/2020
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 coil (subject device) couldn't be delivered out of microcatheter and then the coil (subject device) detached unexpectedly during use.The procedure was completed successfully.The physician replaced it with a new device and finish the procedure without clinical consequences to the patient.
Event or Problem Description
It was reported that during the procedure coil (subject device) couldn't be delivered out of microcatheter and then the coil (subject device) detached unexpectedly during use.The procedure was completed successfully.The physician replaced it with a new device and finish the procedure without clinical consequences to the patient.
Additional Manufacturer Narrative
The subject device is not available; therefore, visual and functional testing as well as physical analysis cannot be performed.The reported complaint could not be confirmed, and it could not be definitively determined if the device failed to meet specifications because the product 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.Information provided by the customer indicated that the device was confirmed to be in good condition prior to use and was prepared as per the dfu, continuous flush was maintained throughout the clinical procedure, and resistance was noted while advancing the coil in the microcatheter.Additionally, it was stated that excessive force was applied while advancing the coil due to friction and the coil prematurely detached.In the case of this complaint, it is most likely that the coil mechanically detached when it was pushed/pulled against resistance.An assignable cause of procedural factors will be assigned to the as reported complaint since this issue appears 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.
Event or Problem Description
It was reported that during the procedure coil (subject device) couldn't be delivered out of microcatheter and then the coil (subject device) detached unexpectedly during use.The procedure was completed successfully.The physician replaced it with a new device and finish the procedure without clinical consequences to the patient.
Additional Manufacturer Narrative
H6 device code grid ¿ corrected ¿ physical resistance/sticking removed.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 main coil was returned detached, but the proximal contact wire was intact.The coil delivery wire was kinked/bent.There was procedural fluid present on the device.The distal tip was found to be intact, but the main coil was stretched.The functional test could not be carried out as the main coil was returned 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.The reported complaint was confirmed based on analysis.The device failed to meet specification when received for complaint investigation based on the analyzed anomalies noted to the device.Information provided by the customer indicated that the device was confirmed to be in good condition prior to use and was prepared as per the dfu, continuous flush was maintained throughout the clinical procedure, and resistance was noted while advancing the coil in the microcatheter.Additionally, it was stated that excessive force was applied while advancing the coil due to friction and the coil prematurely detached.In the case of this complaint, it is most likely that the coil mechanically detached when it was pushed/pulled against resistance.The reported and as analyzed events will be assigned procedural factors as these defects 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 coil delivery wire kinked and bent will be assigned handling damage as the issue is due to handling of the product or portion of the product during the clinical procedure, upon removal of the product from the packaging, or preparation of the product prior to use.

• Brand Name: TARGET XL 360 STANDARD 16MM X 50CM
• 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: 9821407
• Report Number: 3008881809-2020-00061
• Device Sequence Number: 3068886
• Product Code: HCG
• UDI-Device Identifier: 04546540711304
• UDI-Public: 04546540711304
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• 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,Followup
• Report Date (Section B): 07/27/2020

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: 03/09/2022
• Device Model Number: M0036101650
• Device Catalogue Number: M0036101650
• Device Lot Number: 21269667
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2020
• Initial Date Received by Manufacturer: 03/02/2020
• Supplement Date Received by Manufacturer: 04/27/2020; 07/07/2020
• Initial Report FDA Received Date: 03/11/2020
• Supplement Report FDA Received Date: 04/28/2020; 07/27/2020
• 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 MICROCATHETER (STRYKER)
• Patient Age: 56 YR
• Patient Weight: 80