MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XXL 360 8MM X 40CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number M0036180840

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/27/2022

Event Type  malfunction  

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.The device was received.The reported lot number was not confirmed as the packaging was not returned with the device.During visual/microscopic inspection, the coil delivery wire was found to be kinked/bent.The coil introducer sheath was found to be intact.The main coil was found to be broken/fractured.The main coil was found to be kinked/bent.Main coil stretched functional test ¿ not applicable as the defect was not confirmed during visual inspection.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 not confirmed during the analysis.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 and coil delivery wire were found to be kinked/bent.There were no stretches noted.The main coil was found to be broken/fractured.An assignable cause of not confirmed will be assigned to the as reported event of 'main coil stretched' as the defect was not confirmed during the analysis.An assignable cause of procedural factors will be assigned to the as analyzed events of 'main coil broken/fractured during use' and 'main coil kinked/bent' as the defects appear 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.The assignable cause of handling damage will be assigned to the as analyzed event of 'coil delivery wire kinked/bent' as the defect appears to be associated with handling of the product or portion of the product during the procedure.

Event Description

Analysis of returned device revealed that subject main coil was broken/fractured during use.There was no clinical consequence to the patient due to this event.

• Brand Name: TARGET XXL 360 8MM X 40CM
• Type of Device: 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: 15840968
• MDR Text Key: 307738436
• Report Number: 3008881809-2022-00583
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 07613327466423
• UDI-Public: 07613327466423
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K161429
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M0036180840
• Device Catalogue Number: M0036180840
• Device Lot Number: 23345689
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/29/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female