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

Model Number	M0035452020
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The subject device was returned for analysis and the device investigation revealed that the subject main coil was fractured/broken during use.Therefore, this event meets the requirements of a reportable event with an awareness date of 17-feb-2022 (vn).
Additional Manufacturer Narrative
Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the returned coil was found to be broke/fractured, the main coil as found to be stretched and kinked/bent, the suture was found to be damaged and the coil delivery wire was not returned.Catheter friction functional inspection was unable to perform as the main coil was found to broken/fractured.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.During the analysis the main coil was found to be broken/fractured, kinked/bent and stretched.The main coil suture was fond to be damaged as well.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 code 'coil in catheter friction' and to the as analyzed codes 'main coil kinked/bent', 'main coil broken/fractured during use', ' main coil stretched', and 'main coil suture damaged.'.

• Brand Name: TARGET HELICAL NANO 2MM X 2CM
• 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: 13759040
• Report Number: 3008881809-2022-00118
• Device Sequence Number: 5936528
• Product Code: HCG
• UDI-Device Identifier: 07613252600350
• UDI-Public: 07613252600350
• 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): 03/14/2022

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: 08/02/2024
• Device Model Number: M0035452020
• Device Catalogue Number: M0035452020
• Device Lot Number: 23069130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/17/2022
• Initial Report FDA Received Date: 03/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/04/2021
• 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: MICROCATHETER (UNKNOWN)
• Patient Sex: Unknown