MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 ULTRA 4MM X 10CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035424100
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
It was reported during aneurysm embolization case, used a microcatheter to deliver the subject coil.The detachment device showed the successful detachment of the subject coil.The physician prepared to withdraw the delivery wire.However, under the digital subtraction angiography (dsa), the subject coil was still connected with the microcatheter tip.The operator attempted to separate the coil from the catheter but was unsuccessful.Finally, he decided to withdraw the microcatheter and the subject coil out of patient's body together and found the subject coil attached to the tip of the microcatheter.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.
Additional Manufacturer Narrative
D4 expiration date - added d9 product available to stryker ¿ updated d9 returned to manufacturer on ¿updated h3 summary attached - updated h3 device evaluated by mfg ¿updated h4 manufacturing date- added due to the automated manufacturing execution system (mes) there are controls in the manufacturing process to ensure the product met specifications upon release.Visual/microscopic inspection, the main coil was returned protruding out of the distal end of the microcatheter.The main coil was seen to be kinked/bent and stretched.The main coil was seen to be detached.The coil delivery wire was not returned.The coil introducer sheath was not returned.Functional inspection, not required.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 event 'coil jammed was confirmed' and reported 'main coil migration' 'main coil false detachment signal are not confirmed' ; however, the analysis results are consistent with the reported event.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 kinked, jammed, stretched, and also coil was prematurely detached/separated.An assignable cause of procedural factors will be assigned to the as reported/as analyzed 'coil jammed', ' main coil migration' 'main coil false detachment signal' and to the 'main coil prematurely detached/separated during use', 'main coil kinked/bent' 'main coil stretched', as these defects appear to be associated with a product that met stryker design and manufacturing specifications and was used in accordance with the dfu but due to procedural and/or anatomical factors during use, the product performance was limited.
Event or Problem Description
It was reported during aneurysm embolization case, used a microcatheter to deliver the subject coil.The detachment device showed the successful detachment of the subject coil.The physician prepared to withdraw the delivery wire.However, under the digital subtraction angiography (dsa), the subject coil was still connected with the microcatheter tip.The operator attempted to separate the coil from the catheter but was unsuccessful.Finally, he decided to withdraw the microcatheter and the subject coil out of patient's body together and found the subject coil attached to the tip of the microcatheter.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.

• Brand Name: TARGET 360 ULTRA 4MM X 10CM
• 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: 15832230
• Report Number: 3008881809-2022-00579
• Device Sequence Number: 5775653
• Product Code: HCG
• UDI-Device Identifier: 07613252192336
• UDI-Public: 07613252192336
• 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): 02/24/2023

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: 10/20/2024
• Device Model Number: M0035424100
• Device Catalogue Number: M0035424100
• Device Lot Number: 23275296
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/27/2022
• Supplement Date Received by Manufacturer: 01/30/2023
• Initial Report FDA Received Date: 11/21/2022
• Supplement Report FDA Received Date: 02/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/22/2021
• 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: INZONE POWER SUPPLY (STRYKER).; SL-10 MICROCATHETER (STRYKER).; SYNCHRO GUIDEWIRE (STRYKER).
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Race: Asian