MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XXL 360 10MM X 40CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0036181040
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a coil embolization procedure, the subject coil stretched and prematurely detached when it was being repositioned inside of the patient.A pigtail catheter was used to retrieve the detached coil.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
It was reported that during a coil embolization procedure, the subject coil stretched and prematurely detached when it was being repositioned inside of the patient.A pigtail catheter was used to retrieve the detached coil.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
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.During visual inspection the coil delivery wire was seen to be kinked/bent.The main coil was found to be detached/separated and the main coil was seen to be severely stretched.A functional inspection was not required as the reported events were confirming during visual 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 main coil prematurely detached/separated during use and main coil stretched was confirmed during analysis.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.Based off the event description during embolizing of the subject coil, the coil stretched and detached prematurely after several repositioning.There was no damages noted to the device prior to use and continuous flush was not maintained during the procedure.The device was analyzed and the coil delivery wire was noted to be kinked/bent, the main coil was detached and the main coil was stretched.An assignable cause of procedural factors will be assigned to the reported and analysed defects main coil prematurely detached/separated during use 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.Based on the event description, the anatomy was normal.Therefore, an assignable cause of handling damage will be assigned to the analysed defect coil delivery wire kinked/bent as the issue is due to handling of the product or portion of the product during the clinical procedure.According to the event description there was a lot of repositioning which could have contributed to the delivery wire getting damaged.

• Brand Name: TARGET XXL 360 10MM X 40CM
• 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: 16761074
• Report Number: 3008881809-2023-00189
• Device Sequence Number: 3064067
• Product Code: HCG
• UDI-Device Identifier: 07613327128406
• UDI-Public: 07613327128406
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K161429
• 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): 05/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/07/2025
• Device Model Number: M0036181040
• Device Catalogue Number: M0036181040
• Device Lot Number: 23999270
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/22/2023
• Supplement Date Received by Manufacturer: 05/04/2023
• Initial Report FDA Received Date: 04/18/2023
• Supplement Report FDA Received Date: 05/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/09/2022
• 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: CATHETER, PIGTAIL (UNKNOWN)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown