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	01/14/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure, the physician felt resistance upon inserting the coil (subject device) into the microcatheter.The physician proceeded to remove the coil and microcatheter and had identified that the subject coil had detached within the microcatheter.The physician proceeded to remove and exchange both the subject device and microcatheter.The procedure continued and completed without consequences to the patient.
Event or Problem Description
It was reported that during the procedure, the physician felt resistance upon inserting the coil (subject device) into the microcatheter.The physician proceeded to remove the coil and microcatheter and had identified that the subject coil had detached within the microcatheter.The physician proceeded to remove and exchange both the subject device and microcatheter.The procedure continued and completed without 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 the device was returned for analysis and the delivery wire was found kinked/bent and coil was prematurely detached.In the case of this complaint, it is most likely that anatomical or procedural factors resulted difficulty in inserting coil and eventually detached when trying to remove.In the case of this complaint, it is most likely that anatomical or procedural factors resulted difficulty in inserting coil and eventually detached when trying to remove.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 as reported events will be assigned procedural factors as these defects appear to be associated with a product that met stryker and design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural or anatomical factors during use.Therefore an assignable cause of procedural factors will be assigned to the complaint events.An assignable cause of handling damage will also be assigned to the 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: 9635306
• Report Number: 3008881809-2020-00022
• Device Sequence Number: 11396723
• 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): 04/09/2020

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: 05/22/2022
• Device Model Number: M0036128300
• Device Catalogue Number: M0036128300
• Device Lot Number: 21447340
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2020
• Initial Date Received by Manufacturer: 01/15/2020
• Supplement Date Received by Manufacturer: 03/29/2020
• Initial Report FDA Received Date: 01/27/2020
• Supplement Report FDA Received Date: 04/09/2020
• 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 (STRYKER); EXCELSIOR SL-10 (STRYKER)