MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 SOFT 8MM X 30CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0036128300
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/10/2020
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 embolization of renal aneurysm, when coil (subject device) was attempted to insert there was resistance inside the microcatheter and coil was retracted which found out to be prematurely detached and bent of the delivery wire was also noticed.The procedure was completed successfully by placing the detached coil using micro guide wire.No clinical consequences were reported to the patient due to this event.
Event or Problem Description
It was reported that during embolization of renal aneurysm, when coil (subject device) was attemted to insert there was resistance inside the microcatheter and coil was retracted which found out to be prematurely detached and bent of the delivery wire was also noticed.The procedure was completed successfully by placing the detached coil using micro guide wire.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
H4 manufacturing date ¿ added h3 device evaluated by mfg ¿updated h3 summary attached - updated d4 expiration date - added d10 product available to stryker ¿ updated d10 returned to manufacturer on ¿updated d11 concomitant products grid- updated the device was received but the reported lot number was not confirmed as the packaging was not returned with the device.During visual inspection, the coil delivery wire kinked bent.The main coil was not returned.The detachment area could be seen and it looks as this was a mechanical break.Functional inspection was unable to be carried out as the main coil was not available for testing.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 defect of main coil prematurely being detached/separated inside patient¿s anatomy can be confirmed and reported defect of coil in catheter friction could not be confirmed however, the analysis results are consistent with the event.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.The device was returned for analysis and coil was found kinked/bent and prematurely detached.In the case of this complaint, it is most likely that anatomical or procedural factors resulted to jammed during advancement/retraction of the coil and eventually detached when trying to remove.The event 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 or anatomical factors during use.The as reported events will be assigned procedural factors.An assignable cause of handling damage will be assigned to the as analyzed event as it is most likely that the delivery wire kinked due to handling of the device during use.

• Brand Name: TARGET XL 360 SOFT 8MM X 30CM
• 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: 9862958
• Report Number: 3008881809-2020-00069
• Device Sequence Number: 16977246
• Product Code: HCG
• UDI-Device Identifier: 07613327004649
• UDI-Public: 07613327004649
• Combination Product (Y/N): N
• 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): 05/22/2020

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: 10/20/2021
• Device Model Number: M0036128300
• Device Catalogue Number: M0036128300
• Device Lot Number: 20956427
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2020
• Initial Date Received by Manufacturer: 03/10/2020
• Supplement Date Received by Manufacturer: 05/22/2020
• Initial Report FDA Received Date: 03/20/2020
• Supplement Report FDA Received Date: 05/22/2020
• 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: LIGHT HOUSE MICROCATHETER (UNKNOWN MANUFACTURER); LIGHTHOUSE MICROCATHETER (MANUFACURER UNKNOWN)
• Patient Age: 54 YR