MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 SOFT 8MM X 30CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035478300
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The device was returned for analysis and the investigation of the device revealed that the coil(subject device) prematurely detached during use.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.The device was returned and the lot number was confirmed with the packaging returned with the device.During functional inspection the device was found to be returned with catheter.The catheter was found to be intact with no allegations.The main coil was found to be detached and the delivery wire was found to be kinked/bent.The main coil was found to be kinked/bent and stretched.The suture was found to be intact.Functional testing was not performed as it was visually confirmed with the returned 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 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.During analysis, the main coil was found to be stretched, kinked/bent and detached from the delivery wire.An assignable cause of procedural factors will be assigned to the as reported and analyzed event of the main coil stretched and main coil prematurely detached/separated during use as well as the analyzed event of the main coil kinked/bent since this issue 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 and/or anatomical factors during use.An assignable cause of undeterminable will be assigned to as reported event of device interaction with another device as the issue could not be confirmed during analysis.An assignable cause of handling damage will be assign to analyzed event of the coil delivery wire kinked/bent as this defect appears to be associated with handling of the product or portion of the product during the procedure.

• Brand Name: TARGET 360 SOFT 8MM X 30CM
• 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: 14841984
• Report Number: 3008881809-2022-00316
• Device Sequence Number: 2351521
• Product Code: HCG
• UDI-Device Identifier: 04546540676603
• UDI-Public: 04546540676603
• 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): 06/28/2022

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: 01/19/2024
• Device Model Number: M0035478300
• Device Catalogue Number: M0035478300
• Device Lot Number: 22687319
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/10/2022
• Initial Report FDA Received Date: 06/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/20/2021
• 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: AXIUM PRIME COIL (MEDTRONIC); SL-10 MICROCATHETER (STRYKER)
• Patient Sex: Unknown