MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XXL 360 22MM X 50CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number M0036182250

Device Problem Premature Activation (1484)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/02/2017

Event Type  malfunction  

Manufacturer Narrative

The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.During the analysis of the returned device, it was revealed that main coil proximal end was within the catheter hub and the main coil was prematurely detached/ separated due to a physical break at the main coil junction.In addition, blood was also noted in the hub.Functional testing could not be performed due to the condition of the returned device.Additional information reported that the device was confirmed to be in good condition prior to use.The presence of blood on the device indicates insufficient flush though this cannot be conclusively determined.Based on the information currently available and the device inspection, it is probable that the coil was damaged during advancement causing the as reported event.An assignable cause of procedural factors will be assigned to the analysed ¿main coil prematurely detached/separated inside patient' as the issue is associated with a product that meets stryker design and manufacture specifications and was used in accordance with the dfu but due to procedural and/or anatomical factors during use, the device performance was limited.

Event Description

During the analysis of the returned device, it was revealed that the main coil was prematurely detached inside the patient.No clinical consequences reported to the patient.

• Brand Name: TARGET XXL 360 22MM X 50CM
• Type of Device: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• Manufacturer (Section G): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 6942493
• MDR Text Key: 90162210
• Report Number: 3008881809-2017-00438
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 07613327128369
• UDI-Public: (01)07613327128369(17)191031(10)19380822
• Combination Product (y/n): N
• 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: 10/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Model Number: M0036182250
• Device Catalogue Number: M0036182250
• Device Lot Number: 19380822
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/10/2016
• 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