MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET HELICAL NANO 1MM X 3CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035431030
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The subject device was returned for analysis, and it was discovered that the coil (subject device) was found to be prematurely detached/separated during use.There were no clinical consequences to the patient reported as a result of this event.
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 main coil was found to be detached and stuck at the tip of the sl10, the detachment seems to be electrical.The main coil was found to be stretched, the suture was found to be damaged, the main coil was found to be severely kinked/bent at the detachment zone, and the coil delivery wire was not returned.During functional inspection, coil jammed ¿ confirmed during the visual inspection, main coil failed/unable to detach ¿ the coil was found to be detached, and main coil false detachment signal ¿ the coil was found to be detached.An attempt was taken to remove the coil from the microcatheter.The device was flushed, and patency mandrel was advanced; however, the coil could not be pushed out.The coil was pulled out of the distal end of the microcatheter for further analysis.The reported complaint 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.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 main coil was found to be stretched and kinked/bent.The main coil was found to be detached and stuck at the tip.An assignable cause of procedural factors will be assigned to reported/analyzed code 'coil jammed', and to the analyzed codes 'main coil kinked/bent', 'main coil suture damaged', 'main coil prematurely detached/separated during use' and 'main coil stretched' and also to the reported code 'main coil failed/unable to detach' and 'main coil false detachment signal' as this defects appear to be associated with a product that met stryker and design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural or anatomical factors during use.

• Brand Name: TARGET HELICAL NANO 1MM 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: 13477106
• Report Number: 3008881809-2022-00052
• Device Sequence Number: 5437470
• Product Code: HCG
• UDI-Device Identifier: 04546540698018
• UDI-Public: 04546540698018
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 02/07/2022

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: 08/13/2023
• Device Model Number: M0035431030
• Device Catalogue Number: M0035431030
• Device Lot Number: 22368491
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/02/2022
• Initial Report FDA Received Date: 02/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/14/2020
• 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: EXCELSIOR SL-10 (STRYKER MANUFACTURER)
• Patient Sex: Unknown
• Patient Race: Asian