MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 STANDARD 18MM X 50CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number M0036101850

Device Problem Premature Separation (4045)

Patient Problem Insufficient Information (4580)

Event Date 06/13/2022

Event Type  malfunction  

Event Description

It was reported that during the procedure, the subject coil was found prematurely deployed inside the microcatheter.No further information available and there was no clinical consequences were reported to the patient due to this event.

Manufacturer Narrative

The device is not available to the manufacturer.

Manufacturer Narrative

Although the lot number was not provided, the automated manufacturing execution system (mes) has controls in the manufacturing process to ensure the product met specifications upon release.The subject device is not available; therefore, visual and functional testing as well as physical analysis cannot be performed.The reported complaint could not be confirmed, and it could not be definitively determined if the device failed to meet specifications because the product was not returned.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.Additional information provided by the customer indicated that coils prematurely detached in catheter only and one was entirely retrievable.While there are a number of potential causes for the reported issue, because review and analysis of available information failed to identify a definitive cause and the device was not returned, an assignable cause of undeterminable was assigned to this complaint.The device is not available to the manufacturer.

Event Description

It was reported that during the procedure, the subject coil was found prematurely deployed inside the microcatheter.No further information available and there was no clinical consequences were reported to the patient due to this event.

• Brand Name: TARGET XL 360 STANDARD 18MM X 50CM
• 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: 14916048
• MDR Text Key: 302501319
• Report Number: 3008881809-2022-00324
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 07613327004724
• UDI-Public: 07613327004724
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K153658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M0036101850
• Device Catalogue Number: M0036101850
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: MICROCATHETER (UNKNOWN); TARGET XL STANDARD 360 EMBOLIZATION COIL (STRYKER)