MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET HELICAL ULTRA 2MM X 8CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number M0035432080

Device Problem Premature Activation (1484)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/15/2018

Event Type  malfunction  

Manufacturer Narrative

The subject device is not available.

Event Description

It was reported that during the coil embolization procedure, the coil detached prematurely.There were no clinical consequences reported to the patient due to the event.

Event Description

It was reported that during the coil embolization procedure, the coil detached prematurely.There were no clinical consequences reported to the patient due to the event.

Manufacturer Narrative

The device history record review confirms that the device met all material, assembly and performance specifications.The subject device is not available; therefore, functional testing as well as physical analysis cannot be performed.Review and analysis of all available information failed to indicate an assignable cause or probable assignable cause for the reported event.Based on the information available the exact cause for the reported event cannot be determined.

• Brand Name: TARGET HELICAL ULTRA 2MM X 8CM
• Type of Device: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 7265494
• MDR Text Key: 100003081
• Report Number: 3008881809-2018-00068
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• PMA/PMN Number: K112385
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 04/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2020
• Device Catalogue Number: M0035432080
• Device Lot Number: 19761205
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SL-10 MICROCATHETER(STRYKER)