MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 SOFT 5 MM X 10 CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number M0035475100

Device Problem Premature Activation (1484)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/26/2018

Event Type  malfunction  

Manufacturer Narrative

The device is not available to the manufacturer.

Event Description

It was reported that when the coil was advanced in the microcatheter, the coil detached prematurely inside the introducer sheath.There were no reported clinical consequences to the patient.

Manufacturer Narrative

The device history record review confirms that the device met all material, assembly and performance specifications.The main coil was mechanically detached from the delivery wire was not returned for analysis.Visual inspection of the device revealed that the proximal contact and distal delivery wire were kinked likely due to handling.Functional testing could not be performed as the main coil was not returned for analysis.Based on the information currently available, it is probable that some procedural factors encountered during the procedure limited the performance of the coil contributing to the reported damages.Therefore, an assignable cause of operational context has been assigned to this investigation.

Event Description

It was reported that when the coil was advanced in the microcatheter, the coil detached prematurely inside the introducer sheath.There were no reported clinical consequences to the patient.

• Brand Name: TARGET 360 SOFT 5 MM X 10 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: 7364423
• MDR Text Key: 103418006
• Report Number: 3008881809-2018-00132
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• PMA/PMN Number: K153658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2020
• Device Catalogue Number: M0035475100
• Device Lot Number: 19861820
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/17/2017
• 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
• Patient Age: 49 YR