MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 NANO 1MM X 3CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number M0035421030

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/06/2017

Event Type  malfunction  

Manufacturer Narrative

The device history record review confirms that the device met all material, assembly and performance specifications.The subject device was returned with the microcatheter used during the procedure.Visual inspection of the device revealed that the main coil was returned un- attached and broken from the delivery wire at the main coil junction.The main coil was found to be kinked towards the proximal end as well.No other anomalies were observed.Functional testing could not be performed due to the damaged condition of the returned coil.A patency test was performed on the returned microcatheter and no resistance was noted.Information available indicated that the device was confirmed to be in good condition prior to use and was prepared as per the dfu.It is likely that the main coil was damaged during use thus limiting the performance of the coil during the clinical procedure.Therefore, an assignable cause of operational context has been assigned to this investigation.

Event Description

Analysis of the returned device noted that the main coil was broken.No consequences to the patient were reported.

• Brand Name: TARGET 360 NANO 1MM X 3CM
• 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: 7136668
• MDR Text Key: 95532953
• Report Number: 3008881809-2017-00531
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113412
• 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: 12/20/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2019
• Device Catalogue Number: M0035421030
• Device Lot Number: 19222199
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/27/2017
• Initial Date FDA Received: 12/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/2016
• 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