MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 NANO 2MM X 3CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035442030
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 device returned together with microcatheter, the coil delivery wire was found to be kinked/bent in multiply areas, the main coil was found to be broken/fractured inside the microcatheter.It was pushed out using patency mandrel, the main coil was found to be broken/fractured, the main coil was found to be stretched, the main coil was found to be kinked/bent.A functional inspection, was unable to perform as the main coil was found to be broken/fractured inside the microcatheter.The catheter was flushed, and the patency mandrel was inserted to push out the coil; however significant friction was noted, and the patency mandrel stuck in the proximal part of the microcatheter.The patency mandrel was inserted from the distal end of the microcatheter, and the coil was pushed out.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 could not be 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 broken/fractured inside the returned microcatheter which indicates that the coil was advanced into the catheter during the procedure.The main coil as found to be kinked/bent and stretched.The coil delivery wire was found to be kinked/bent.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 codes 'coil introducer sheath friction', 'main coil difficulty inserting' and to the as analyzed codes 'main coil broken/fractured during use', 'main coil stretched', 'main coil kinked/bent.' an assignable cause of 'handling damage' will be assigned to as analyzed code 'coil delivery wire kinked/bent' as these defects appear to be associated with handling of the product or portion of the product during the procedure.
Event or Problem Description
The coil (subject device) was returned for analysis, and it was discovered that the main coil (subject device) was broken/fractured during use.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.

• Brand Name: TARGET 360 NANO 2MM X 3CM
• 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: 17559540
• Report Number: 3008881809-2023-00421
• Device Sequence Number: 3640251
• Product Code: HCG
• UDI-Device Identifier: 07613252600312
• UDI-Public: 07613252600312
• 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
• Report Date (Section B): 08/16/2023

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: 12/06/2023
• Device Catalogue Number: M0035442030
• Device Lot Number: 22616534
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/01/2023
• Initial Report FDA Received Date: 08/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/07/2020
• 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: SL-10 MICROCATHETER (STRYKER)
• Patient Sex: Unknown