MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 SOFT 5MM X 15CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035475150
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the left acoma aneurysm embolization procedure, a guidewire and guide catheter were used to select the ica c2.The guidewire was retracted to insert the subject coil.It was reported that friction was noted inside the shaft when advancing the subject coil in the proximal of the microcatheter.When the subject coil was retracted, it was noted that it got fractured at the detachment zone and got separated from its delivery wire inside the microcatheter.The separated subject coil was removed along with the removal of microcatheter.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 e1 initial reporter phone 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 coil delivery wire was seen to be kinked/bent.There was suture damage.The main coil was seen to be severely stretched.There were no breaks seen along the main coil during analysis.The delivery wire was seen to be broken fractured.Functional inspection was not performed due to returned condition of the coil 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.An assignable cause of 'not confirmed' was assigned to the as reported 'coil in catheter friction' and 'main coil prematurely detached/separated during use' as the issue 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.This complaint appears to be associated with a product that met stryker design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural factors during use.Therefore, an assignable cause of procedural factors will be assigned to the as analyzed aa 'main coil suture damage', 'main coil stretched' and 'coil delivery wire broken/fractured during use'.An assignable cause of handling damage will be assigned to the as analyzed 'coil delivery wire kinked/bent' as it is most likely that the delivery wire kinked due to handling of the device during use.
Event or Problem Description
It was reported that during the left acoma aneurysm embolization procedure, a guidewire and guide catheter were used to select the ica c2.The guidewire was retracted to insert the subject coil.It was reported that friction was noted inside the shaft when advancing the subject coil in the proximal of the microcatheter.When the subject coil was retracted, it was noted that it got fractured at the detachment zone and got separated from its delivery wire inside the microcatheter.The separated subject coil was removed along with the removal of microcatheter.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• Brand Name: TARGET 360 SOFT 5MM X 15CM
• 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: 12145646
• Report Number: 3008881809-2021-00294
• Device Sequence Number: 4581009
• Product Code: HCG
• UDI-Device Identifier: 04546540676504
• UDI-Public: 04546540676504
• 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): 01/19/2022

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: 09/30/2023
• Device Model Number: M0035475150
• Device Catalogue Number: M0035475150
• Device Lot Number: 22474028
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/15/2021
• Supplement Date Received by Manufacturer: 12/27/2021
• Initial Report FDA Received Date: 07/09/2021
• Supplement Report FDA Received Date: 01/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2020
• 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: EXCELSIOR XT- 17 MICROCTHETER ( STRYKER); NEUROFORM ATLAS STENT (STRYKER); SYNCHRO GUIDEWIRE (STRYKER); TARGET COILS (STRYKER); UNKNOWN 6F GUIDE CATHETER; UNKNOWN SLIM GUIDEWIRE
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Race: Asian