MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 SOFT 3MM X 8CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035473080
Medical Device Problem Codes	Fracture (1260); Expulsion (2933)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2022
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 procedure, when third of the coil (subject device) was inserted into aneurysm, the operator found no reaction from the manipulation.When checked under dsa, it was found that the coil (subject device) was fractured.The operator tried to push and pull the coil (subject device) several times, it could not move.So the operator retraced rest of the coil (subject device) with delivery wire out, and used a guidewire to push part of the coil (subject device) which was out of the aneurysm to go into aneurysm slowly.The procedure was completed successfully.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 d9 product available to stryker ¿ updated d9 returned to manufacturer on ¿updated due to the automated mes (manufacturing execution system) system, there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the coil delivery wire was found to be severely kinked/bent and the main coil was found to be intact.A functional test was not performed.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 main coil broken/fractured during use was not confirmed during the analysis.The reported main coil protrusion could not be confirmed during the analysis as the event is procedure/patient related.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.The device was analyzed.The main coil was found to be intact.No breakage/fracture was noted.An assignable cause of 'not confirmed' will be assigned to the as reported 'main coil broken/fractured during use' as the defect was not confirmed during the analysis.An assignable cause of undeterminable will be assigned to the reported 'main coil protrusion', as there are a number of potential causes for the reported issue, because review and analysis of available information failed to identify a definitive cause.An assignable cause of handling damage will be assigned to the 'coil delivery wire kinked/bent' since it is most likely that this damage occurred due to handling of delivery wire during the clinical procedure.
Event or Problem Description
It was reported that during procedure, when third of the coil (subject device) was inserted into aneurysm, the operator found no reaction from the manipulation.When checked under dsa, it was found that the coil (subject device) was fractured.The operator tried to push and pull the coil (subject device) several times, it could not move.So the operator retraced rest of the coil (subject device) with delivery wire out, and used a guidewire to push part of the coil (subject device) which was out of the aneurysm to go into aneurysm slowly.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• Brand Name: TARGET 360 SOFT 3MM X 8CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer (Section G): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 14844396
• Report Number: 3008881809-2022-00318
• Device Sequence Number: 14612568
• Product Code: HCG
• UDI-Device Identifier: 04546540676436
• UDI-Public: 04546540676436
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 08/17/2022

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: 06/29/2022
• Device Model Number: M0035473080
• Device Catalogue Number: M0035473080
• Device Lot Number: 21559872
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/09/2022
• Supplement Date Received by Manufacturer: 08/04/2022
• Initial Report FDA Received Date: 06/28/2022
• Supplement Report FDA Received Date: 08/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: HEADWAY 17 MICROCATHETER (NON-STRYKER); TARGET COILS (STRYKER); TRAXCESS GUIDEWIRE (NON-STRYKER)
• Patient Sex: Unknown
• Patient Race: Asian