MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET HELICAL NANO 2 MM X 3 CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number M0035452030

Device Problem Premature Activation (1484)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/03/2017

Event Type  malfunction  

Manufacturer Narrative

The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.Only the delivery wire was returned without the coil.Visual examination of the returned device revealed that target coil delivery wire was kinked/bentlikely due to handling.In addition, the main coil appeared to have physically detached from the delivery wire.Functional testing could not be performed on the returned device due to the condition in which it was returned.Follow up attempts were made to the customer to obtain additional information associated with the returned device; however, no further information is available.Information available indicated that the coil could not be advanced through the microcatheter (unknown manufacturer).Based on the information available and analysis of the returned device, the exact cause for the observed detachment of the coil from the delivery wire cannot be determined.

Event Description

Based on the analysis of the device, it was found that the main coil was physically detached from the delivery wire.There were no reported patient consequences.

• Brand Name: TARGET HELICAL NANO 2 MM X 3 CM
• 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: 7177422
• MDR Text Key: 96815984
• Report Number: 3008881809-2018-00028
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 07613252600367
• UDI-Public: (01)07613252600367(17)200430(10)19706311
• Combination Product (y/n): N
• Reporter Country Code: KR
• PMA/PMN Number: K113412
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Model Number: M0035452030
• Device Catalogue Number: M0035452030
• Device Lot Number: 19706311
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/24/2017
• 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