MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 SOFT 5MM X 15CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number M0036125150

Device Problems Break (1069); Premature Activation (1484)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/05/2017

Event Type  malfunction  

Manufacturer Narrative

The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.Visual inspection of the device revealed that the delivery wire was kinked/bent due to handling.Further analysis, it was observed that the main coil had detached at the detachment zone (physical break) and the main coil was found broken.In addition, the main coil was stretched and coil suture was damaged.A function evaluation could not be performed due to the condition of the device.The returned device appeared to be severely damaged, it is likely that the damage was sustained to the main coil during the procedure and contributing to the reported event.Based on the analysis of the device and available information, an assignable cause of operational context was assigned to the reported event.

Event Description

Analysis of the returned product revealed that the main coil was prematurely detached inside the patient and the main coil was broken.There were no clinical consequences reported to the patient due to this event.

• Brand Name: TARGET XL 360 SOFT 5MM X 15CM
• 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: 6852700
• MDR Text Key: 85438816
• Report Number: 3008881809-2017-00297
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123377
• 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: 09/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2020
• Device Catalogue Number: M0036125150
• Device Lot Number: 19593542
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/07/2017
• 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 MANUFACTURER)