MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 SOFT 6MM X 30CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035476300
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3 other text : the device is not available to the manufacturer.
Event or Problem Description
It was reported that during the procedure, the physician tried to return the subject coil from aneurysm after kick back however, could not move the subject coil and microcatheter.The subject coil deployed prematurely and end of the coil invaded the parent vessel.The physician then deployed a stent.No further information is available.
Event or Problem Description
It was reported that during the procedure, the physician tried to return the subject coil from aneurysm after kick back however, could not move the subject coil and microcatheter.The subject coil deployed prematurely and end of the coil invaded the parent vessel.The physician then deployed a stent.No further information is available.
Additional Manufacturer Narrative
Due to the automated manufacturing execution system (mes), there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device is not available; therefore, functional testing as well as visual testing cannot be 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 complaint could not be confirmed, and it could not be definitively determined if the device failed to meet specifications because the product was not returned.While there are a number of potential causes for the reported issue, because review of available information failed to identify a definitive cause and the device was not returned for analysis, an assignable cause of 'undeterminable' was assigned to as reported "main coil prematurely detached/separated during use".
Additional Manufacturer Narrative
G4 pma/510(k - corrected.D4 gtin: corrected.D9 product available to stryker: updated.D9 returned to manufacturer on: updated.H3 device evaluated by mfg: updated.Due to the automated manufacturing execution system (mes) there are controls in the manufacturing process to ensure the product met specifications upon release.During visual and microscopic inspection, it was observed that the subject coil delivery wire was seen to be kinked/bent.The main coil was found to be detached/separated from the delivery wire.Functional test was not required as event was confirmed during analysis.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 complaint was confirmed based on analysis of the returned device.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.The device was returned for analysis, and it was noted that the coil delivery wire was seen to be kinked/bent.The mail coil was found to be detached/separated from the delivery wire.The reported event was confirmed during analysis.Based on a review of all available information and the analysis of the returned device it is probable that while trying to adjust the coil at the desired location, the coil detached prematurely due to procedural factors.The as reported and as analyzed codes: main coil prematurely detached/separated during use and as analyzed code: coil delivery wire kinked/bent will be assigned a probable cause of procedural factors as 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.
Event or Problem Description
It was reported that during the procedure, the physician tried to return the subject coil from aneurysm after kick back however, could not move the subject coil and microcatheter.The subject coil deployed prematurely and end of the coil invaded the parent vessel.The physician then deployed a stent.No further information is available.

• Brand Name: TARGET 360 SOFT 6MM X 30CM
• 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: 19166762
• Report Number: 3008881809-2024-00176
• Device Sequence Number: 7949048
• Product Code: HCG
• UDI-Device Identifier: 04546540676559
• UDI-Public: (01)04546540676559(17)260627(10)24392119
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K112385
• 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,Followup
• Report Date (Section B): 01/10/2025

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: 06/27/2026
• Device Catalogue Number: M0035476300
• Device Lot Number: 24392119
• 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: 03/29/2024
• Supplement Date Received by Manufacturer: 06/18/2024; 12/21/2024
• Initial Report FDA Received Date: 04/23/2024
• Supplement Report FDA Received Date: 07/10/2024; 01/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/29/2023
• 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: LVIS STENT (MICROVENTION).; MICROCATHETER (UNKNOWN).
• Patient Sex: Unknown