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

Model Number	M0035425150
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is not available to manufacturer.
Event or Problem Description
It was reported that during the procedure of mca aneurysm embolization, a microcatheter was used to build access and delivered a coil (subject device) to go into the aneurysm and prepared to detach it.The tail of delivery wire was inserted to go into the detachment device and the instillation was normal.The detachment button was pressed and waited for more than 10 seconds but the subject coil was not detached.So, the delivery wire was taken out and tried to insert again and the detachment attempt was made again, but the coil was still not able to be detached.Finally when the physician prepared to take the tail of delivery wire out of detachment device, it was found that the tail of delivery wire of the subject device was fractured in the detachment device.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.
Event or Problem Description
It was reported that during the procedure of mca aneurysm embolization, a microcatheter was used to build access and delivered a coil (subject device) to go into the aneurysm and prepared to detach it.The tail of delivery wire was inserted to go into the detachment device and the instillation was normal.The detachment button was pressed and waited for more than 10 seconds but the subject coil was not detached.So, the delivery wire was taken out and tried to insert again and the detachment attempt was made again, but the coil was still not able to be detached.Finally when the physician prepared to take the tail of delivery wire out of detachment device, it was found that the tail of delivery wire of the subject device was fractured in the detachment device.The physician replaced it with a new device and continued the procedure without clinical 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.D9 product available to st0ryker ¿ updated.D9 returned to manufacturer on ¿updated.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 noted to be broken/ fractured at the proximal contact junction and was also noted to be kinked/bent.The main coil advanced through the introducer sheath without issue.There were no anomalies noted to the returned main coil.Functional inspection could not be performed due to the coil delivery wire broken/fracture at the proximal contact junction.The reported event was confirmed.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.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.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 reported and as analyzed main coil failed/unable to detach and coil delivery wire broken/fractured during use.The as analyzed event of coil delivery wire kinked/bent will be assigned handling damage as this complaint appears to be associated with handling of the product or portion of the product during the procedure, a probable cause of handling damage was assigned.

• Brand Name: TARGET 360 ULTRA 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
• MDR Report Key: 12063672
• Report Number: 3008881809-2021-00274
• Device Sequence Number: 3647845
• Product Code: HCG
• UDI-Device Identifier: 04546540675965
• UDI-Public: 04546540675965
• 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): 09/29/2021

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: 01/13/2023
• Device Model Number: M0035425150
• Device Catalogue Number: M0035425150
• Device Lot Number: 22052342
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2021
• Initial Date Received by Manufacturer: 06/03/2021
• Supplement Date Received by Manufacturer: 09/09/2021
• Initial Report FDA Received Date: 06/24/2021
• Supplement Report FDA Received Date: 09/29/2021
• 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); INZONE POWER SUPPLY (STRYKER)
• Patient Age: 76 YR