MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 STANDARD 16MM X 50CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0036101650
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after detachment of the subject coil, when the delivery wire was pulled thinking the subject coil was detached successfully since three beep sound was heard.However, it had not been detached.Then the subject coil was reinserted, but it could not be operated as expected.The subject coil was retrieved, and found it was stretched and prematurely detached inside the microcatheter.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.D4 lot # - corrected from 610165 to 24101552.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 not returned with the coil, the main coil was found to be stretched, the main coil was also seen to be tangled, and the main coil was found to be detached/separated.A functional inspection for the reported events 'main coil prematurely detached/separated during use' and 'main coil stretched' was not available as the defect was confirmed during analysis.A functional inspection for the reported even 'main coil false detachment signal' was not available as only main coil was returned.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 was confirmed based on analysis.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.Additional information provided by the customer is the device was prepared for use as per the dfu.There was no damage noted to the packaging prior to opening the packaging.The device was confirmed to be in good condition during preparation/ prior to use on the patient.After detachment of the coil, when the delivery wire was pulled back it was noted the coil had not detached.Then the coil was reinserted, but the coil could not be operated as expected.So, the coil was retrieved, and found it was stretched and prematurely detached.An assignable cause of procedural factors will be assigned to the as reported 'main coil prematurely detached/separated' during use, 'main coil stretched' and 'main coil false detachment signal' as these defects 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.An assignable cause of procedural factors will be assigned to the as analyzed 'main coil prematurely detached/separated during use', 'main coil tangled' and 'main coil stretched' as these defects 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 after detachment of the subject coil, when the delivery wire was pulled thinking the subject coil was detached successfully since three beep sound was heard; however, it had not been detached.Then the subject coil was reinserted, but it could not be operated as expected.The subject coil was retrieved, and found it was stretched and prematurely detached inside the microcatheter.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.

• Brand Name: TARGET XL 360 STANDARD 16MM X 50CM
• 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: 17561461
• Report Number: 3008881809-2023-00422
• Device Sequence Number: 6684413
• Product Code: HCG
• UDI-Device Identifier: 04546540711304
• UDI-Public: 04546540711304
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 08/30/2023

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: 01/14/2026
• Device Catalogue Number: M0036101650
• Device Lot Number: 24101552
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/04/2023
• Supplement Date Received by Manufacturer: 08/21/2023
• Initial Report FDA Received Date: 08/16/2023
• Supplement Report FDA Received Date: 08/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2023
• 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: INZONE POWER SUPPLY (STRYKER); MICROCATHETER (UNKNOWN ); TARGET COIL (STRYKER)
• Patient Sex: Unknown